MRI in Predicting Response in Patients Receiving Combination Chemotherapy and Bevacizumab For Advanced or Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This randomized phase II trial is studying how well MRI works in predicting response to combination chemotherapy given together with bevacizumab in treating patients with advanced or metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania; University of Pennsylvania
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Calcium; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

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