Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments bevacizumab, oxaliplatin, capecitabine
Phase phase 2
Target VEGF
Sponsor Herbert Hurwitz, MD
Collaborator National Cancer Institute (NCI)
Start date September 2003
End date January 2008
Trial size 50 participants
Trial identifier NCT00416494, CDR0000449971, DUMC-4951-05-7R2, GENENTECH-DUMC-4951-05-7R2, Pro00008646, ROCHE-DUMC-4951-05-7R2, SANOFI-DUMC-4951-05-7R2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bevacizumab
10 mg/kg intravenously over 30-90 minutes on day 1
oxaliplatin
85 mg/m2 intravenously over 2 hours on day 1.
capecitabine
Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
(Experimental)
bevacizumab
10 mg/kg intravenously over 30-90 minutes on day 1
oxaliplatin
85 mg/m2 intravenously over 2 hours on day 1.
capecitabine
Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Primary Outcomes

Measure
Response Rate (Percentage of Participants With Partial or Complete Response)
time frame: After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.

Secondary Outcomes

Measure
Time to Progression
time frame: From time of treatment until documented progression, assesed up to 60 months.
Disease Free Survival
time frame: From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.
Overall Survival
time frame: From time of treatment until death from any cause, assesed up to 60 months.
Safety and Tolerability
time frame: After all participants went off study drug regimine.

Eligibility Criteria

Male or female participants at least 18 years old.

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 < 2.5 times upper limit of normal (ULN) (5 times ULN if known liver metastases) - Bilirubin < 1.5 times ULN - Creatinine clearance > 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 < 140/90 mm Hg on any new regimen for at least 3 different observations over 14 days - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during study and for at least 3-4 months after study completion - No arterial or venous thrombosis (including cerebrovascular accident) within the last 3 months - No known, existing, uncontrolled coagulopathy - No clinically significant cardiac disease - No congestive heart failure - No symptomatic coronary artery disease - No cardiac arrhythmias not well controlled with medication - No myocardial infarction within the last 12 months - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, capecitabine, or bevacizumab - No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications PRIOR CONCURRENT THERAPY: - At least 4 weeks since prior sorivudine or brivudine - At least 6 months since prior adjuvant treatment with fluorouracil and leucovorin calcium or a fluorouracil and leucovorin calcium-based regimen - No major surgery within 4 weeks without complete recovery - No prior chemotherapy for metastatic/recurrent disease - No cancer immunotherapy or other biologic therapy while on therapy - No radiotherapy while on study - No hormonal therapy for cancer while on study - No full-dose warfarin (INR of > 1.5), heparin (> 10,000 units/day), or thrombolytic agents - Allopurinol and cimetidine should be discontinued prior to starting on this regimen

Additional Information

Official title Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer
Principal investigator Herbert I. Hurwitz, MD
Description OBJECTIVES: Primary - Evaluate the response rate in patients with previously untreated metastatic colorectal cancer treated with capecitabine, oxaliplatin, and bevacizumab. Secondary - Assess time to progression (TTP), disease-free survival (DFS), and overall survival (OS) in patients treated with this regimen. - Assess the safety and tolerability of bevacizumab, oxaliplatin, and capecitabine in patients with previously untreated metastatic colorectal cancer. Exploratory - Evaluate the effect of this regimen on the biomarkers of angiogenesis. - Assess the effect of this regimen on wound angiogenesis. OUTLINE: Patients receive oral capecitabine twice daily on days 1-5 and 8-12, oxaliplatin IV over 2 hours on day 1, and bevacizumab IV over 1-1½ hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Duke University.