Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer
Colon Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00193219 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Drug); Cetuximab (Drug); 5-fluorouracil (Drug); Leucovorin (Drug); Oxaliplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
55 | — |
| SECONDARY Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease |
9 | — |
| SECONDARY Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death |
25.7 | — |
| SECONDARY Number of Patients With Adverse Events as a Measure of Safety With FOLFOX6 Combined With Bevacizumab and Cetuximab |
31 | — |
Summary
Eligibility Criteria
Inclusion Criteria
To be included in the study, you must meet the following criteria:
- Metastatic colorectal cancer confirmed by a biopsy sample
- 18 years of age or older
- Evidence of disease progression at time of study entry
- At least one prior adjuvant chemotherapy regimen
- No prior therapy for metastatic disease
- Measurable disease
- Able to perform activities of daily living with minimal assistance
- Adequate bone marrow, kidney, and liver function
- Tumor tissue available for assessment of EGFR
- Signed informed consent
Exclusion Criteria
You cannot participate in the study if any of the following apply to you:
- Treatment with a previous regimen for metastatic disease
- Prior treatment with any EGFR inhibitor or anti-angiogenic agents
- Brain or nervous system metastases
- History of severe thromboembolic event
- Clinical evidence or history of bleeding or coagulopathy
- History of stroke or heart attack within six months
- Poorly controlled hypertension
- Non-healing wound, ulcer, or bone fracture
- History of abdominal fistula, perforation, or abscess within six months
- Other uncontrolled or significant disease or medical condition
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Data sourced from ClinicalTrials.gov (NCT00193219). 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.