Status:
WITHDRAWN
FOLFOX/Bevacizumab +/- MK-0646 in Metastatic Colorectal Cancer
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose is to study the efficacy (effectiveness) of a new drug, MK-0646, in metastatic colorectal cancer. MK-0646 is an investigational or experimental anti-cancer agent that has not yet been appr...
Detailed Description
Participants randomized to ARM A will receive modified FOLFOX 7 every other week + MK-0646 every week: 5-FU 400 mg/m2 by intravenous infusion over 2-5 minutes Leucovorin 400 mg/m2 by intravenous infu...
Eligibility Criteria
Inclusion
- Metastatic colorectal adenocarcinoma.
- Measurable disease by RECIST criteria.
- Adequate hepatic function: total bilirubin ≤2.0 x upper limits of normal (ULN); Aspartate Amino Transferase (AST)/Alanine Amino Transferase (ALT) ≤3.0X upper limits of normal (or ≤5X upper limits of normal if attributable to liver metastases).
- Adequate renal function: serum creatinine ≤2.0 mg/dl.
- Adequate bone marrow function: absolute neutrophil count ≥1,500/mm3; platelets ≥ 100,000/mm3.
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) levels ≤1.5 upper limit of normal (unless patients receiving coumadin anticoagulation in which case a stable international normalized ratio (INR) of 2-3 is required).
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy ≥ 12 weeks.
- Negative pregnancy test.
- Ability to sign informed consent.
Exclusion
- Prior systemic chemotherapy for metastatic colorectal cancer
- Prior oxaliplatin in the adjuvant setting within 12 months
- Uncontrolled central nervous system metastases or carcinomatous meningitis.
- Myocardial infarction in the past 6 months.
- Major surgery within 8 weeks prior to enrollment.
- Uncontrolled serious medical or psychiatric illness.
- Inadequately controlled hypertension (defined as systolic blood pressure \>160mmHg, or diastolic blood pressure \> 100mmHg).
- Pregnant or lactating women. Both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of study.
- Prior experimental therapy targeting the IGF-1 pathway
- Concurrent malignancy (with the exception of squamous or basal cell skin carcinoma)
- Planned surgical metastasectomy
- Patient has known hypersensitivity to components of treatment, their analogs, or drugs of similar chemical or biologic composition
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01175291
Start Date
September 1 2010
End Date
July 1 2012
Last Update
December 5 2011
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