Phase 2
N=50
Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00416494 ↗Enrolled (actual)
50
Serious AEs
30.0%
Results posted
Mar 2013
Primary outcome: Primary: Response Rate (Percentage of Participants With Partial or Complete Response) — 63; 42 percentage of participants with response
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab (Biological); oxaliplatin (Drug); Capecitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Herbert Hurwitz, MD
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (Percentage of Participants With Partial or Complete Response) |
63; 42 | — |
| SECONDARY Time to Progression |
10.1; 10.4 | — |
| SECONDARY Disease Free Survival |
10.1; 10.4 | — |
| SECONDARY Overall Survival |
19.6; 24.8 | — |
| SECONDARY Safety and Tolerability |
19; 29 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, and oxaliplatin, 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, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically documented adenocarcinoma of the colon or rectum
- Metastatic or recurrent disease not amenable to potentially curative treatment (e.g., inoperable metastatic disease)
- No leptomeningeal or brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- AST/ALT 50 mL/min
- No unstable or poorly controlled hypertension (> 150/100 mm Hg)
- Patients who have recently started or adjusted antihypertensive medications are eligible provided blood pressure is 1.5), heparin (> 10,000 units/day), or thrombolytic agents
- Allopurinol and cimetidine should be discontinued prior to starting on this regimen
Data sourced from ClinicalTrials.gov (NCT00416494). 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.