Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated

NCT00025337 | Completed Phase 3

• 4 other identifiers: NCI-2012-02417E3200U10CA021115CDR0000068951
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have advanced or metastatic colorectal cancer that has been previously treated. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells. It is not yet known if bevacizumab is more effective with or without combination chemotherapy in treating colorectal cancer

Conditions

Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage III Colon Cancer; Stage III Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From the date of entry on study, assessed up to 5 years

Secondary Outcomes (2)

• Response defined using RECIST criteria

  Up to 5 years

• Progression free survival

  From the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, assessed up to 5 years

Study Arms (3)

Arm I (bevacizumab, oxaliplatin, leucovorin, fluorouracil)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1. Patients also receive leucovorin calcium IV over 2 hours and fluorouracil (5-FU) IV over 22 hours on days 1 and 2.

Biological: bevacizumab; Drug: oxaliplatin; Drug: leucovorin calcium; Drug: fluorouracil

Arm II (oxaliplatin, leucovorin calcium, fluorouracil)

EXPERIMENTAL

Patients receive oxaliplatin, leucovorin calcium, and 5-FU as in arm I.

Drug: oxaliplatin; Drug: leucovorin calcium; Drug: fluorouracil

Arm III (bevacizumab)

EXPERIMENTAL

Patients receive bevacizumab as in arm I.

Biological: bevacizumab

Interventions

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Arm I (bevacizumab, oxaliplatin, leucovorin, fluorouracil); Arm III (bevacizumab)

oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Arm I (bevacizumab, oxaliplatin, leucovorin, fluorouracil); Arm II (oxaliplatin, leucovorin calcium, fluorouracil)

leucovorin calcium DRUG

Given IV

Also known as: CF, CFR, LV

Arm I (bevacizumab, oxaliplatin, leucovorin, fluorouracil); Arm II (oxaliplatin, leucovorin calcium, fluorouracil)

fluorouracil DRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU

Arm I (bevacizumab, oxaliplatin, leucovorin, fluorouracil); Arm II (oxaliplatin, leucovorin calcium, fluorouracil)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the colon or rectum
• Advanced or metastatic disease
• Must have received a fluoropyrimidine-based regimen and an irinotecan-based regimen, either alone or in combination, for advanced disease
• May have relapsed within 6 months of adjuvant therapy with fluorouracil (5-FU) (or combination 5-FU and irinotecan) and progressed after single-agent irinotecan
• Measurable disease
• No known brain metastases
• Performance status - ECOG 0-2
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• No history of thrombotic or hemorrhagic disorders
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST no greater than 5 times ULN
• INR no greater than 1.5
• PTT no greater than ULN
• Creatinine no greater than 1.5 times ULN

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab; Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bruce Giantonio

  Eastern Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 2001
• Primary Completion: April 1, 2007
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)