Study Stopped
Administratively complete.
Combination Chemotherapy and Bevacizumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Colorectal Cancer
A Phase III Trial of Modified FOLFOX6 Versus CAPOX, With Bevacizumab (NSC-704865) or Placebo, as First-Line Therapy in Patients With Previously Untreated Advanced Colorectal Cancer
4 other identifiers
interventional
2,200
1 country
1
Brief Summary
Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, and capecitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen with bevacizumab works better in treating colorectal cancer. This randomized phase III trial is studying giving two different combination chemotherapy regimens together with bevacizumab and comparing how well they work in treating patients with locally advanced, metastatic, or recurrent colorectal cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2003
CompletedFirst Posted
Study publicly available on registry
October 7, 2003
CompletedStudy Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedJanuary 25, 2013
January 1, 2013
2.8 years
October 3, 2003
January 24, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival in patients with colorectal cancer treated with fluorouracil/leucovorin calcium and oxaliplatin with and without becavizumab versus those treated with capecitabine and oxaliplatin with our without bevacizumab
Will be analyzed primarily by the stratified Cox model.
Up to 6 years
Secondary Outcomes (7)
Time to treatment failure
Up to 6 years
Progression-free survival
Up to 6 years
Response (among patients with measurable disease)
Up to 6 years
Treatment toxicities graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 3.0)
Up to the time of progression
Change in FACT-C TOI
Baseline to 25 weeks
- +2 more secondary outcomes
Study Arms (2)
Arm I (oxaliplatin, leucovorin calcium, fluorouracil)
EXPERIMENTALPatients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1. Patients are further randomized to receive bevacizumab or placebo\* IV over 30-90 minutes on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: \*As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
Arm II (oxaliplatin, capecitabine)
EXPERIMENTALPatients receive oxaliplatin IV over 2 hours on day 1and oral capecitabine on days 1-15. Patients are further randomized to receive bevacizumab or placebo\* as in arm I. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity NOTE: \*As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
Interventions
Given IV
Given IV
Given orally
Given IV
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed locally advanced, recurrent, or metastatic colorectal adenocarcinoma
- Not curable by surgery or amenable to radiotherapy with curative intent
- Previously resected colorectal cancer with new evidence of metastasis does not require separate histologic or cytologic confirmation unless one of the following is true:
- More than 5 years has elapsed between primary surgery and development of metastatic disease
- Primary tumor was T1-T2, N0, M0
- Site of primary lesion must be or have been in the large bowel as determined by endoscopy, radiology, or surgery
- Measurable or evaluable disease
- No known brain or leptomeningeal disease
- Performance status - Zubrod 0-2
- No history of hemorrhagic or thrombotic disorders
- Absolute neutrophil count greater than 1,500/mm\^3
- Platelet count greater than 100,000/mm\^3
- Bilirubin no greater than 2.0 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN (5 times ULN for patients with liver involvement)
- Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN for patients with liver involvement or 10 times ULN for patients with bone involvement)
- +43 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southwest Oncology Group
San Antonio, Texas, 78245, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Blanke
SWOG Cancer Research Network
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2003
First Posted
October 7, 2003
Study Start
April 1, 2004
Primary Completion
January 1, 2007
Last Updated
January 25, 2013
Record last verified: 2013-01