MRI in Predicting Response in Patients Receiving Combination Chemotherapy and Bevacizumab For Advanced or Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring recurrent colon cancer, recurrent rectal cancer, stage III colon cancer, stage III rectal cancer, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum
Patients receiving bevacizumab must have tumor tissue available for immunohistochemical analysis
- Formalin-fixed, paraffin-embedded tissue from previous biopsy or surgical resection is sufficient
Measurable disease, defined by RECIST as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques (i.e., CT or MRI)
- CEA elevation alone is insufficient for study entry
- No known brain metastases
PATIENT CHARACTERISTICS:
Criteria for all patients
- ECOG performance status 0-1
- Life expectancy > 3 months
- Granulocytes ≥ 1,500/mL
- Platelet Count ≥ 100,000/mL
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- AST ≤ 5 times ULN
- Urine protein:creatinine ratio ≤ 1.0 at screening
- Patients with other prior malignancies are eligible, provided they have been treated with curative intent and have no evidence of recurrence
- Not pregnant or nursing
- Negative pregnancy test
No contraindications to MRI, including any of the following:
- Hypersensitivity to gadolinium
- Metallic device, including pacemaker, non-MRI compatible aneurysm clip, other non-MRI-compatible mechanical and/or electrical device, or metallic fragments
- Severe claustrophobia
Additional criteria for patients receiving bevacizumab:
- No significant traumatic injury within the past 28 days
- No serious nonhealing wounds, ulcers, or bone fractures
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No myocardial infarction, unstable angina, or cerebrovascular accident within the past 6 months
- No clinically significant peripheral vascular disease
- No New York Heart Association class II-IV congestive heart failure
- Patients with pre-existing hypertension should be on a stable antihypertensive regimen with blood pressure ≤ 150/100 mm Hg at study entry
PRIOR CONCURRENT THERAPY:
Criteria for all patients
- Prior adjuvant treatment including oxaliplatin allowed
- No prior bevacizumab
- At least 14 days since prior radiotherapy and recovered
- More than 6 months since prior chemotherapy
- No other concurrent investigational agents
Additional criteria for patients receiving bevacizumab:
- At least 28 days since prior major surgical procedure or open biopsy
- At least 7 days since prior minor surgical procedure (e.g., fine-needle aspirations or core biopsies)
- No anticipation of need for a major surgical procedure during study treatment
- Concurrent oral or parenteral anticoagulation therapy allowed provided dose is stable
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Arm I
Arm II
FOLFOX alone (control)
Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours (FOLFOX) beginning on day 1. Patients also receive bevacizumab at 5 mg/kg IV over 90 minutes on day 1. Treatment repeats every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.
Patients receive FOLFOX as in arm I and bevacizumab at 10 mg/kg IV over 90 minutes on day 1. Treatment repeats every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.
Patients receive FOLFOX as in arm I.