Cetuximab Plus Combination Chemotherapy in Treating Patients With Stage IV Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00020917
First received: July 11, 2001
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cetuximab with combination chemotherapy in treating patients who have stage IV colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Biological: cetuximab
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Pilot Study of an Anti-Epidermal Growth Factor Receptor (EGFR) Antibody, Cetuximab, in Combination With Irinotecan, Fluorouracil, and Leucovorin, and in Patients With Newly Diagnosed Stage IV Colorectal Carcinoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: February 2001
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the safety profile of cetuximab, irinotecan, leucovorin calcium, and fluorouracil in patients with stage IV colorectal cancer. II. Determine the response rate and time to progression in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours once weekly on weeks 1-6. Patients also receive irinotecan IV over 90 minutes, leucovorin calcium IV over 10-15 minutes, and fluorouracil IV over 3-5 minutes once weekly on weeks 1-4. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage IV colorectal cancer Any T, any N, M1 Immunohistochemical evidence of epidermal growth factor receptor expression (at least 1+) Bidimensionally measurable metastatic disease Meningeal or CNS involvement by tumor allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin normal AST no greater than 5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history of uncontrolled angina, arrhythmias, or congestive heart failure Neurologic: No uncontrolled seizure disorder No active neurological disease No grade 2 or greater neuropathy Other: No other malignancy within the past 3 years except basal cell skin cancer or pre-invasive carcinoma of the cervix No medical or psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No prior cetuximab Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy for stage I, II, or III colorectal cancer allowed only if disease-free for more than 1 year from completion of therapy until the first evidence of metastatic disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for metastatic disease No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery (excluding prior diagnostic biopsy) Other: No prior treatment for metastatic colorectal cancer At least 30 days since prior investigational agents

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020917

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Leonard B. Saltz, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00020917     History of Changes
Other Study ID Numbers: 01-037, CDR0000068730, IMCL-CP02-0038, NCI-G01-1969
Study First Received: July 11, 2001
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage IV colon cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Cetuximab
Fluorouracil
Levoleucovorin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on October 19, 2014