Phase 2
Completed N=66
Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer
Adenocarcinoma of the Rectum · Mucinous Adenocarcinoma of the Colon · Recurrent Colon Cancer · Recurrent Rectal Cancer
Source: ClinicalTrials.gov NCT00100841 ↗
Enrolled (actual)
66
Serious AEs
81.8%
Results posted
Jul 2015
Primary outcomePrimary: Severe Adverse Event (SAE) Rate — 2; 2 participants
Summary
Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab and cetuximab may kill more tumor cells. This phase II trial is studying how well giving combination chemotherapy together with bevacizumab and cetuximab works in treating patients with stage IV colorectal cancer that cannot be removed by surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severe Adverse Event (SAE) Rate |
2; 2 | — |
| PRIMARY Progression Free Survival Rate |
9.6 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum which is beyond the scope of surgical resection (MEDRA code:"Colorectal neoplasms malignant","Colorectal cancer stage IV","10010035")
- Measurable disease,
- Life expectancy of greater than 3 months
- ECOG performance status = = 3,500/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 150,000/uL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) = = 1+ proteinuria will undergo a 24-hour urine collection, which will be < 1000 mg protein/ 24 hours to be allowed participation in the study
- No currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix; patients are not considered to have a "currently active" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years
- Patients with clinically significant cardiovascular disease:
- Uncontrolled hypertension
- Myocardial infarction or unstable angina < 6 months prior to registration
- New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris
- Grade II or greater peripheral vascular disease
- CVA within 6 months of study entry
Data sourced from ClinicalTrials.gov (NCT00100841). 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. Informational only — not medical advice.