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

Completed · Phase 1/Phase 2

Conditions studied: Rectal Cancer, Adenocarcinoma of the Rectum

In brief

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.

Key facts

Study ID

NCT00307736

Run by

Massachusetts General Hospital

People needed

32

Starts

2006-05-01

Expected to finish

2011-07-01

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.