Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer

NCT00077298 | Completed Phase 2

• 10 other identifiers: NCI-2012-01445MSKCC-03135NCI-6444CDR000035008603-1356444N01CM17105N01CM17101N01CM17103N01CM17102
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial is studying giving bevacizumab and cetuximab together with irinotecan to see how well it works compared to giving bevacizumab and cetuximab alone in treating patients with irinotecan-refractory metastatic colorectal cancer. Monoclonal antibodies such as cetuximab and bevacizumab 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 deliver tumor -killing substances to them. Drugs used in chemotherapy, such as irinotecan, also work in different ways to kill tumor cells or stop them from growing. Giving cetuximab and bevacizumab together with irinotecan may improve the ability to block tumor growth.

Conditions

Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Time to tumor progression

  Date of randomization to the date of either documentation of disease progression, or death, assessed up to 3 years

Secondary Outcomes (2)

• Objective response rate

  Up to 3 years

• Overall survival

  Up to 3 years

Study Arms (2)

Arm A (cetuximab, bevacizumab, irinotecan)I

EXPERIMENTAL

Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36; bevacizumab IV over 30-90 minutes on days 1\*, 15, and 29 OR on days 1 and 22; and irinotecan IV over 30-90 minutes (at the same dose and schedule that the patient previously received) beginning on day 1. NOTE: \*Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses.

Biological: cetuximab; Biological: bevacizumab; Drug: irinotecan hydrochloride; Other: laboratory biomarker analysis

Arm B (cetuximab and bevacizumab)

EXPERIMENTAL

Patients receive cetuximab as in Arm A and bevacizumab IV over 30-90 minutes on days 1\*, 15, and 29. NOTE: \*Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses.

Biological: cetuximab; Biological: bevacizumab; Other: laboratory biomarker analysis

Interventions

cetuximab BIOLOGICAL

Given IV

Also known as: C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225

Arm A (cetuximab, bevacizumab, irinotecan)I; Arm B (cetuximab and bevacizumab)

bevacizumab BIOLOGICAL

Given IV

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

Arm A (cetuximab, bevacizumab, irinotecan)I; Arm B (cetuximab and bevacizumab)

irinotecan hydrochloride DRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E

Arm A (cetuximab, bevacizumab, irinotecan)I

laboratory biomarker analysis OTHER

Correlative studies

Arm A (cetuximab, bevacizumab, irinotecan)I; Arm B (cetuximab and bevacizumab)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed colorectal cancer
• Metastatic disease by diagnostic imaging studies
• Measurable disease
• At least 1 unidimensionally measurable lesion with minimum lesion size at least twice the slice thickness of the imaging study used
• Refractory to irinotecan, evidenced by clinical documentation
• Received at least 1 prior irinotecan-containing chemotherapy regimen for metastatic disease and progressed during or within 6 weeks after completion of therapy
• Must have received prior irinotecan according to 1 of the following schedules:
• Weekly administration with a starting dose of 100-125 mg/m\^2
• Biweekly administration (every other week) with a starting dose of approximately 180 mg/m\^2
• Once every three weekly administration with a starting dose of 300-350 mg/m\^2
• No known brain metastases
• No prior primary CNS tumors
• Performance status - ECOG 0-1
• Performance status - Karnofsky 80-100%
• More than 3 months

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Cetuximab; Bevacizumab; Irinotecan

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; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Leonard Saltz

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 11, 2004
• Study Start: December 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: April 15, 2015

Record last verified: 2012-12

Locations

US (1)