Status:
COMPLETED
Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Conditions:
Rectal Cancer
Adenocarcinoma of the Rectum
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 begi...
Detailed Description
* All participants will receive the following drugs: 5-fluorouracil (5-FU) given as a continuous 24-hour infusion; Bevacizumab given intravenously; erlotinib given orally at home. In the Phase I porti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00307736
Start Date
May 1 2006
End Date
July 1 2011
Last Update
May 10 2017
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115