Presentation on theme: "MD Anderson Cancer Center CCOP Research Base Update 2011"— Presentation transcript:
1MD Anderson Cancer Center CCOP Research Base Update 2011 Michael J. Fisch, MD, MPH, FACPChair, Department of General OncologyDivision of Cancer MedicineTwitter:
2Objectives Review our membership and accrual Discuss some study data Describe and discuss our active studiesSummarize CCOP Strategic PlanExplore our future togetherWhat do we do well?What will be the indicators of success in the future?
6Accrual 28 patients / Goal 72 Treatment: Active(NCI 7341) A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, with Pegfilgrastim for the Treatment of Patients with Metastatic Transitional Cell Carcinoma and Renal InsufficiencyPrincipal Investigator: Lance C. Pagliaro, MD, MD Anderson Cancer CenterMethodology: Single-arm phase II protocolPatients with CrCL< 60 ml/min receivedoxorubicin 40 mg/m2 IV over 20 min;paclitaxel 135 mg/m2 IV over 60 min;gemcitabine 900 mg/m2 IV over 90 min;Pegfilgrastim 6 mg SC on day 1 or day 2Courses repeated every 14 daysPatient Population:Metastatic or unresectable transitional cell (TCC) carcinoma of bladder, urethra or upper urinary tract.Mixed TCC and variant histologies (small cell, squamous, adenocarcinoma, sarcoma) are permitted if present in < 50% of the biopsy specimen.Accrual 28 patients / Goal 72Top Enrolling Sites: MD Anderson, Ozarks CCOPPreliminary Results: Poster presented at GU ASCO February, 2011. Results: Twenty-five pts enrolled and 21 could be assessed for response. Median (range) age was 72.8 years (53.4, 89.3) and 8 pts (32.0%) were female. RECIST responses occurred in 12 pts (4 complete; 8 partial), for an overall response rate of 57.1% (95% CI ). Notable grade 3 and 4 toxicities were anemia (9 pts), thrombocytopenia (3 pts), neutropenia (2 pts), dyspnea (1 pt), mucositis (1 pt), and sepsis (1 pt). No adverse events were attributed to same-day pegfilgrastim and there were no treatment-related deaths. Eleven pts (44.0%) died of progressive disease; the median (range) follow-up time for 14 surviving pts was 5.5 months (2.3, 17.5). Conclusions: GTA has been well-tolerated in the setting of renal insufficiency, with an observed response rate in advanced UC exceeding the targeted response. The study will continue to a maximum of 72 pts.
8Treatment: CNPEID (NCI 3410) A Prospective Randomized Phase III Trial Comparing Consolidation Therapy with or without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate CancerPrincipal Investigator: Shi-Ming Tu, MD, MD Anderson Cancer CenterPatient Population: A total of 265 patients with androgen-independent prostate cancer were enrolled. Closed to new patient entry 10/20/2010.Top Enrolling CCOP Sites: MD Anderson – Orlando, Marshfield Clinic, Wichita CCOP, Central Illinois CCOPPreliminary Results: PendingRANDOMIZEOption 1Ketoconazole/doxorubicinAlternating withEstramustine/vinblastineOption 2Prednisone/docetaxelSr-89 plus doxorubicin x 6 weeksClinical Response16 weeksDoxorubicin x 6 weeks
9Treatment: CNPE(NCI 6636) A Randomized, Factorial-Design, Phase II Trial of Temozolomide Alone and in Combination with Possible Permutations of Thalidomide, Isotrentinoin and/or Celecoxib as Post-Radiation Adjuvant Therapy of Glioblastoma MultiformePrincipal Investigator: Mark R. Gilbert, MD, M. D. Anderson Cancer CenterPatient Population:178 patients with a diagnosis of supratentorial glioblastoma multiforme enrolled. Closed to new patient entry 02/24/2011.Top Enrolling CCOP Sites: Atlanta CCOP, Kansas City CCOP, Central Illinois CCOPPreliminary Results: Pending
10Treatment: CNPE(NCI 6485) A Phase II Study of Rituximab-CHOP with Pegylated Liposomal Doxorubicin in Patients Older than 60 Years of Age with Untreated Aggressive B-Cell Non-Hodgkin’s LymphomaMethodology:Rituximab 375 mg/m2 IVPB on day 1, administered 1stCyclophosphamide 750 mg/m2 IVPB on day 1Pegylated liposomal doxorubicin 40 mg/m2 IV over 1hr day 1Vincristine 2.0 mg IV, day 1Prednisone 40 mg/m2 PO days 1-5GCSF 5 mcg/kg, SC daily, start on day 5, until neutrophil recovery (>3000/ul) ORPegylated GCSF 6 mg SC x 1 (24 hours after chemotherapy)Patient Population: At total of 80 patients, older than 60 years of age with untreated aggressive B-cell NHL, enrolled. Closed to new patient entry 05/18/2009.Top Enrolling CCOP Sites: Maimonides Medical Center, Grand Rapids CCOPResults: 80 pts total were enrolled on study; 79 were eligible and evaluable for response and toxicity. Characteristics of pts: age years (median 71); 41 female. All had at least one cardiac risk factor. Responses were: 55 CR (69%); 14 PR. (17%) At a median follow-up of 2.7 years, 62 are alive (77%), with 78% progression free survival. There were 7 grade 3 adverse cardiac events: 1 drop in LVEF; 4 atrial arrhythmias (reversed); 1 hypotension (reversed); 1 chest pain (reversed). Troponin and BNP changes did not correlate with cardiac events. Other grade 3-4 non-hematologic events: 3 hand-foot syndrome; 4 fatigue; 2 DVT; 2 neuropathy. Only one death occurred on study due to pneumonia, non-neutropenic. The most common grade 3-4 toxicity events were hematologic.Conclusions: DRCOP is an active regimen. In this study of older pts with DLBCL, only one pt had drop in LVEF below normal. Other cardiac events were associated with underlying cardiac conditions, and were reversible. Liposomal doxorubicin should be considered in older patients. Comanagement by a Cardiologist during chemotherapy would be recommended.
11Summary of Protocol Findings (NCI 6485) A Phase II Study of Rituximab-CHOP with Pegylated Liposomal Doxorubicin in Patients Older than 60 Years of Age with Untreated Aggressive B-Cell Non-Hodgkin’s LymphomaTreatment: CNPESummary of Protocol Findings80 patients were enrolled on the trial and evaluated for response, cardiotoxicity, and myelosuppression.74 patients were evaluable for response after 4 courses of therapy.54 (73%) patients achieved a CR / 14 (19%) patients achieved a PRThe overall response rate was 92%.Response assessment after 8 courses of therapy was performed on 63 evaluable patients.The overall response rate for the 63 evaluable patients after 8 cycles was 89%.
12Summary of Protocol Findings (NCI 6485) A Phase II Study of Rituximab-CHOP with Pegylated Liposomal Doxorubicin in Patients Older than 60 Years of Age with Untreated Aggressive B-Cell Non-Hodgkin’s LymphomaTreatment: CNPESummary of Protocol FindingsOf the 80 patients enrolled, 12 (15%) patients reported grade 3 cardiac events, including hypotension (3), tachycardia (1), hypertension (2), decreased ejection fraction (1), chest pain (2), arrhythmia (3), coronary artery disease (1), acute coronary syndrome and diastolic dysfunction (1), TIA (1), and pericarditis (1).Other Grade 3-4 toxicities reported in >10% of patients were: fatigue (27), leucopenia (31), lymphopenia (35), neutropenia (34), and anemia (12).
13Treatment: CNPE(NCI 7548) Single-arm, Open-label, Phase II Trial of Rituximab plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-cell Lymphoma in AdultsNew Principal Investigator Nathan Fowler, MD, MD Anderson Cancer CenterPatient Population: A total of 52 patients with newly diagnosed follicular B cell lymphoma were enrolled. Closed to new patient entry 05/01/2009.Top Enrolling CCOP Sites: Wichita CCOP, Grand Rapids CCOP
14Summary of Protocol Findings (NCI 7548) Single-arm, Open-label, Phase II Trial of Rituximab plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-cell Lymphoma in AdultsTreatment: CNPESummary of Protocol Findings52 pts were enrolled on study, and all were eligible for assessment. The median age was 56 (31-78), and 62% were male.56% of patients had intermediate or high risk FLIPI. Fifteen (29%) pts had bulky disease (>5cm), and 29 (56%) pts had elevated B2M.Tolerance was good; and effects attributable to GM-CSF were minor. Absolute granulocyte count (AGC) elevation above 15K occurred in only 4% of pts; conversely, ≥ grade 3 neutropenia occurred in 8 pts. No significant infections occurred.
15Summary of Protocol Findings (NCI 7548) Single-arm, Open-label, Phase II Trial of Rituximab plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-cell Lymphoma in AdultsTreatment: CNPESummary of Protocol FindingsAt 3 months, the overall response rate was 69%, including 23% of pts with a CR. With continued follow up, response rates improved (ORR 74%, CR 42%). Twenty four (46%) pts remain in remission without further treatment. At a median follow up of 14 months the median PFS of all pts was 28 months, including pts with bulky disease (median PFS of 16 mo). No difference in PFS was observed when comparing FLIPI score (0-1) vs (2-3) or B2M.Conclusion: Rituximab plus GM-CSF is well tolerated and active in untreated pts with FL. There did not appear to be significant difference in outcomes when comparing FLIPI scores, although PFS was inferior in patients with bulky disease. Randomized studies are required to determine whether this combination is superior to rituximab as a single agent.
17Cancer Control: Active (NCI CCC01-06) Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M. D. Anderson Cancer Center and M. D. Anderson Community Clinical Oncology ProgramPrincipal Investigators: Jon Hunter MD, Mount Sinai Hospital, TorontoLorenzo Cohen, PhD, MD Anderson Cancer CenterCommunity Co-Investigator: Dedra Glover, AS, CCRP, Scott & White CCOPMethodology: Patients with newly-diagnosed cancer, who are about to undergo chemotherapy, and give informed consent, will be randomly assigned to one of three groups:Mindfulness Relaxation group [MR];Relaxing Music group [RM] where participants will listen to music for the same amount of time as the MR participants receive their intervention;Standard Care control group where participants will receive standard medical education on chemotherapy [SC].Patient Population: The study population will consist chemotherapy naive cancer patients schedule to undergo at least 4 cycles of chemotherapy treatment. Target accrual 400 subjects (including 25 on pilot). Current accrual 284.Top Enrolling CCOP Sites: Scott & White CCOP, Michigan Cancer Research Consortium, San Juan MBCCOP
18(NCI CCC01-06) Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M. D. Anderson Cancer Center and M. D. Anderson Community Clinical Oncology ProgramAdditional training and intervention recording being held March 5, 2011.Planned protocol revision March, 2011 to remove exclusion criteria excluding patients with concrete planned immune therapy as part of the their treatment regimen and/or within 3 months of completing chemotherapy. Examples include GCSF, GMCSF,IL2, and/or Interferon.
192006-0198 (NCI MDA 2006-0198) CAM Use and Cancer Cancer Control: Active(NCI MDA ) CAM Use and CancerPrincipal Investigator: Patricia Ann Parker, PhD, MD Anderson Cancer CenterPatient Population:. Oncology nurses with regular interactions with patients who are at least one week post diagnosis of cancer and not greater than 6 months post treatment target accrual.Top Enrolling CCOP Sites: Metro-Minnesota CCOP, Central Illinois CCOP, Grand Rapids Clinical Oncology Program, Boston Medical CenterRandom Assignment to Intervention or Waitlist ControlEnrollment of Nurses/Providers at Participating CCOPs1 WeekBaseline Patient AssessmentBaseline Provider AssessmentBaseline Provider AssessmentCD/Video and Resource ListProvider and Patient Follow-Up Assessment2 WeeksProvider and Patient Follow-up Assessment2 MonthsCD/Video and Resource List
20Preliminary Findings – ASCO 2010 Cancer Control: Active(NCI MDA ) CAM Use and CancerPreliminary Findings – ASCO 2010Patients were 65% female, 86% non-Hispanic white, average age of 59 (range 23-88), and 30% had a college degree or higher.The most common cancers were breast cancer (31%), lung cancer (12%), and colorectal cancer (10%). 39% indicated that they have used one or more CAM therapies following their cancer diagnosis.
212006-0198 (NCI MDA 2006-0198) CAM Use and Cancer Cancer Control: ActivePreliminary Findings ContinuedThe most common categories of CAM used by patients were:massage therapy (19%)relaxation techniques (19%)special diet (18%)megavitamins (15%)Reasons for using CAM included:believes CAM beneficial (27%)to address the emotional and spiritual aspects of the disease (23%)and to boost immune system (21%)
222006-0198 (NCI MDA 2006-0198) CAM Use and Cancer Cancer Control: ActivePreliminary Findings ContinuedPatients indicated that 9% of their physicians and 12% of nurses had asked them about their use of CAM at that oncology visit.Twenty-one percent of patients reported that they initiated a discussion with their providers about their use of CAM and the most common responses were: encouraged me to continue (13%) and was neutral (7%). Reasons for not telling healthcare practitioners about CAM use included: my healthcare provider never asked (27%) and unsure if CAM beneficial (18%).
232006-0198 (NCI MDA 2006-0198) CAM Use and Cancer Cancer Control: ActiveConclusions:More than one third of patients indicated that they used some type of CAM therapy and the majority of their providers did not ask them about their CAM use. There remains considerable uncertainty among patients about the role of CAM in the context of cancer care.
26Promote Clinical Trials Instantly share IRB approved clinical trial flyers with a global audienceUploaded approved flyer to web serverShorten URL atPaste trial title and URL into Twitter update box.Done!Why Bit.ly?Shortens URL – Twitter limits you to 140 charactersMetrics. See how many people click on your links.This process works with any file type. It isn’t just for clinical trials.
27Focused DiscussionsHashtags are keywords that “tag “ a conversation so that readers can easily find all relevant tweets/comments. They’re great for conferences!Creating a hashtag is easy1. Any word in your tweet that starts with a pound sign is a hashtag. That’s all you have to doTwitter makes hashtags “clickable” automatically. Clicking on one reveals the entire conversation thread. You can create your own or use others (as long as your input is relevant).Examples:#mdacctrials#pediatrics#oncology#ASPHO2010
28(NCI MDA ) Randomized, Double-Blind, Placebo-Controlled Trial of Palonosetron/ Dexamethasone with or without Dronabinol for the Prevention of Chemotherapy-induced Nausea and Vomiting after Moderately Emetogenic ChemotherapyCancer Control: ActivePrincipal Investigator: P. K. Morrow, MD, MD Anderson Cancer CenterSteven Grunberg, MD, University of VermontCommunity Co-Investigator: Jeffery Giguere, MD, Greenville CCOPMethodology:Palonosetron 0.25 mg IV and dexamethasone 10 mg IV 30 minutes prior to chemo administration. Randomized to take dronabinol 5 mg or matched placebo: 1 tablet by mouth 3 times a day for 5 days beginning 30 minutes before chemotherapy.Follow-up physical examination and assessment between day14 through 28.Primary endpoint will be Total Protection: No Vomiting, No Rescue Therapy and no Nausea during the overall (0-120 hour) period.Patient Population: Population will be 100 patients in each treatment group (200 patients total).Patients ≥18 years old, documented solid tumor, receiving first time chemotherapy. Currently 40 enrolled of 200 target accrual.Enrolling CCOP Sites: Christus St. Frances Cabrini, Marshfield Clinic, Greenville CCOP
29Planned protocol revision March, 2011 (NCI MDA ) Dronabinol/Placebo for the Prevention of CINV for Moderately Emetogenic ChemotherapyCancer Control: ActivePlanned protocol revision March, 2011Allow the addition of regimens that give taxanes before Adriamycin and/or CytoxanPatients will be eligible after any number of cycles iftaxane given as part of planned regimen such T→ACPatient has no N/V with taxane cycles
30Cancer Control: Active (NCI MDA ) Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients with Metastatic Colorectal CancerPrincipal Investigator: Bryan Kee, MD, M. D. Anderson Cancer CenterMethodology:CASAD / placebo will be provided by Salient Pharmaceuticals incapsules that are taken as 2 capsules four times daily.Recently revised and sent to sites for approval. Major changes: inclusion of patients with ostomies, less restrictive lab requirements including ANC, and revision of UGT1A1 criteria.Patient Population: A maximum of 100 patients will be randomized equally between two arms, 50 per arm. Current accrual 56.Enrolling CCOP Sites: Scott & White CCOP, Greenville CCOP, Columbia River CCOP6 WeeksCASAD Off Study/Optional Additional 6 WeeksPlacebo Off Study/Optional Additional 6 WeeksR
31Cancer Control: Active (NCI a) A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe TreatmentPrincipal Investigator: Daniel J. Lenihan, MD, Vanderbilt UniversityMichael Fisch, MD, MD Anderson Cancer CenterCommunity Co-Investigator: Steven Wolff, MD, Meharry Medical College MBCCOPMethodology:The biomarkers (BNP and Troponin I) will be obtained as a point of care test with meter, kits, controls and training provided by the protocol. Patients will be assessed during each visit prior to each cycle of therapy until therapy completion and then at 6 and 12 months after the initiation of chemotherapy to identify cardiotoxicity.Patient Population: A total of 830 patients starting a new anthracycline chemotherapy regimen will be enrolled.Enrolling CCOP Sites: Meters, kits and controls have been provided to 18 CCOP, Main Member and academic sites. Additional meters will be available in March, Currently 9 enrolled of 830 target.
32(NCI a) A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe TreatmentCancer Control: ActiveEligible DiseasesMost enrollments will be patients with Non-Hodgkin’s Lymphoma or breast cancerCan be any disease being treated with a regimen that uses an anthracycline including: Hodgkin’s, multiple myeloma, AML, ALL, sarcoma, Kaposi’s sarcoma, bladder, SCLC, NSCLC, gastric, ovarian and prostate
33Acceptable Anthracyclines (NCI a) A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe TreatmentCancer Control: ActiveAcceptable Anthracyclinesdoxorubicin (Adriamycin)doxorubicin liposomal (Doxil)daunorubicin (Cerubidine)daunorubicin liposomal (DaunoXome)epirubicin (Ellence)idarubicin (Idamycin)mitoxantrone (Novantrone)valrubicin (Valstar)
34Length of anthracycline regimen: Anthracycline administration: Cancer Control: Active(NCI a) A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe TreatmentLength of anthracycline regimen:Any, Q14 days, Q21 days, Q28 daysAnthracycline administration:Bolus or continuous infusionMinimum anthracycline dose:anyAnthracycline regimen:single agent or multiple agent regimen
35Prefer echocardiogram Cancer Control: Active(NCI a) A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe TreatmentEchocardiogramPrefer echocardiogramMay use Muga scan if used consistently throughout the trialMuga provides limited information, is more expensive, and exposes patient to more radiationProtocol revision in progress to clarify this point
36Cancer Control: Active (MDA ) Comparative Study of Oncologist Recommended, Home-Based Exercise Program and Relaxation Training for Physical Functioning and Symptom Control in Colon Cancer PatientsPrincipal Investigator: Karen Basen-Engquist, PhD, MD Anderson Cancer CenterMethodology:Patient Population: A total of 150 patients with metastatic colon cancer will be accrued to this protocol.Enrolling CCOP Pilot Sites: Wichita CCOP, Scott & White CCOP, Michigan Cancer Research Consortium. Currently 2 enrolled of 150 target.
38(NCI CCC 03-27) Prevention of Cisplatin- or Oxaliplatin-induced Peripheral Neuropathy with Alpha-lipoic Acid: A Placebo-controlled Phase III TrialCancer Control: CNPEPrincipal Investigator: Ying Guo, MD, MD Anderson Cancer CenterMethodology:Patient Population: A total of 244 patients who were scheduled to receive chemotherapy that contains platinum in the regimen were enrolled. Closed to new patient enrollment 11/02/2009.Top Enrolling CCOP Sites: Metro-Minnesota CCOP, Wichita CCOP, Greenville CCOP, Marshfield Clinic, Christus St Frances Cabrini Hospital
39(NCI CCC 03-27) Prevention of Cisplatin- or Oxaliplatin-induced Peripheral Neuropathy with Alpha-lipoic Acid: A Placebo-controlled Phase III TrialCancer Control: CNPEOf 243 pts randomized, 121 pts (51%) completed treatment for 12 weeks. At 24 weeks, only 34 evaluable pts remained in the ALA group, and 36 in the placebo group (p= 0.75). No statistical difference was noted in dose intensity for the oxaliplatin arm of the ALA group and the placebo group (median of 765 mg/m2 vs mg/m2, p=0.18).No significant differences were noted for either FACT/GOG-NTX scores (p=0.70), neurotoxicity (p=0.87), or best tumor responses between the 2 groups (p=0.85).
40Cancer Control: CNPE(NCI CCC 03-27) Prevention of Cisplatin- or Oxaliplatin-induced Peripheral Neuropathy with Alpha-lipoic Acid: A Placebo-controlled Phase III TrialConclusions:Oral ALA 600 mg PO TID was ineffective at preventing neurotoxicity caused by oxaliplatin or cisplatin.Intense schedules of oral agents in the symptom/toxicity prevention setting created adherence challenges due to pill size and frequency of administration.Poor adherence might affect the power to detect ALA’s effectiveness in this trial.Innovative drug delivery and trial designs are needed to further explore alpha lipoic acid in the prevention and/or reduction of chemotherapy-induced neuropathy.
42Cancer Control: Proposed (MDA 04-01) A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients with Head and Neck CancerPrincipal Investigator: Joseph S. Chiang, MD, MD Anderson Cancer CenterMethodology:Protocol Status: NCI Approved, IRB Approval PendingPatient Population: A total of 150 patients who have received radiation for the treatment of head and neck cancer will be enrolled.Enrolling CCOP Sites: Sites should have a relationship with board certified acupuncturists who will participate in training to do fixed acupuncture on a placebo controlled protocol.
43Call will be led by faculty from the Integrative Medicine Program (MDA 04-01) A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients with Head and Neck CancerCancer Control: ProposedConference call/webinar to be held with interested sites in March, 2011.Call will be led by faculty from the Integrative Medicine ProgramLorenzo Cohen, PhDKay Garcia, MSN, MPH, DrPH (acupuncturist)Subcontracts will be implemented with participating sites to provide pass through funds for acupuncture.Training videos will be provided for sites/acupuncturists
44Principal Investigator: Richard Lee, MD, MD Anderson Cancer Center (Not Yet Assigned) A Phase I Study of Sublingual Anvirzel (Nerium Oleander) in Advanced Non-Small Cell Lung CancerCancer Control: ProposedPrincipal Investigator: Richard Lee, MD, MD Anderson Cancer CenterMethodology: All subjects will receive SL Anvirzel dosing beginning 3 days prior to starting chemotherapy. A total of four dose cohorts will be evaluated (0.8, 1.6, 2.4, 3.2 ml/m2/day; SL q8hrs) with 7 patients per cohort.Protocol Status: NCI Concept Submission PendingPatient Population: Newly diagnosed advanced non-small cell lung cancer patients scheduled to receive four cycles of carboplatin and docetaxel chemotherapy. Total accrual goal of 28 patients.
45Not Yet Assigned Nano-curcumin in Breast Cancer Prevention in the Contralateral Breast Cancer Control: ProposedPrincipal Investigator: Banu K. Arun, MD, MD Anderson Cancer CenterProtocol Status: NCI Concept Submission PendingPatient Population: Breast Cancer Patients
46Protocol Status: NCI Concept Submission Pending Not Yet Assigned BIG Study: Time Out for Reflection in the Course of ChemotherapyCancer Control: ProposedPrincipal Investigator: Jon Hunter, MD, Mount Sinai Hospital, Toronto, Michael J. Fisch, MD Anderson Cancer Center, Lorenzo Cohen, PhD, MD Anderson Cancer CenterProtocol Status: NCI Concept Submission PendingPatient Population: Cancer Patients
47CCOP Strategic PlanIncoroporate emerging science and novel trial designsSurvivorship, tx toxicities, risk assessmentUse epi and biologic data from underrepresented populationsImprove clinical trial participation
48Winning the future? What are our biggest assets at MDACC? What do we do best?What should we do best (but aren’t yet)?Creative ideas moving forward?