Phase 2
N=32
Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer
Rectal Cancer · Adenocarcinoma of the Rectum
Bottom Line
View on ClinicalTrials.gov: NCT00307736 ↗Enrolled (actual)
32
Serious AEs
25.0%
Results posted
May 2017
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Erlotinib When Administered in Combination With 5-fluorouracil (5-FU), Bevacizumab, and External Beam Radiation Therapy — 100 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 5-fluorouracil (Drug); bevacizumab (Drug); erlotinib (Drug); External beam radiation therapy (EBRT) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Erlotinib When Administered in Combination With 5-fluorouracil (5-FU), Bevacizumab, and External Beam Radiation Therapy |
100 | — |
| SECONDARY Summary of Grade 3 or Greater Toxicity |
16; 5; 6; 0; 3; 0 | — |
| SECONDARY Percentage of Participants With Disease-free Survival |
93.4; 83.4; 75.5 | — |
| SECONDARY Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy. |
4; 2; 2; 1; 1; 5 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00307736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.