Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is determine the safety of 5-fluorouracil, bevacizumab and erlotinib when administered in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating(Phase II portion) patients with locally advanced rectal cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Dana-Farber Cancer Institute; Genentech, Inc.
• Treatments: Bevacizumab; Erlotinib Hydrochloride; Fluorouracil

Criteria

Inclusion Criteria:

• Histologically confirmed primary adenocarcinoma of the rectum that begins within 15cm of the anal verge as determined by sigmoidoscopy or colonoscopy

• Clinical T3 or T4 tumors as determined by endoscopic ultrasound and/or rectal MRI

• ECOG performance status of 0-2

• 18 years of age or older

• Creatinine of < 2.0

• Adequate hepatic function

• Adequate hematopoietic function

• Use of effective means of contraception in subjects of child-bearing potential

Exclusion Criteria:

• Evidence of metastatic disease as determined by chest/abdominal/pelvic CT or physical exam

• Prior chemotherapy or radiation therapy for treatment of colorectal cancer

• Prior treatment with 5-FU

• Prior treatment with a tyrosine kinase inhibitor, EGFR inhibitor, or VEGF inhibitor

• Patients must not be receiving any other investigational agent

• Prior malignancy within the last 5 years except for completely excised skin cancer, in situ cervical cancer

• Warfarin anticoagulation

• Co-existent malignant disease

• Current or recent participation in a clinical trial (within 4 weeks from the first day of treatment)

• Pregnancy

• Blood pressure of >150/100 mmHg

• Unstable angina

• NYHA Grade II or greater congestive heart failure

• History of myocardial infarction within 6 months

• History of stroke within 6 months

• Clinically significant peripheral vascular disease

• Evidence of bleeding diathesis or coagulopathy

• Presence of central nervous system or brain metastases

• Major surgical procedure, open biopsy, or significant trauma injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the course of the study

• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0

• Pregnant or lactating

• Urine protein:creatinine ratio > or equal to one at screening

• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0]

• Serious, non-healing wound, ulcer, or bone fracture