Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00556413
First received: November 9, 2007
Last updated: May 13, 2011
Last verified: May 2011
  Purpose

RATIONALE: Monoclonal antibodies, such as cetuximab, 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 carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Efficacy and Safety of cétuximab Associated With the Protocol FOLFIRINOX (LV5FU Simplified Combined With Irinotecan and Oxaliplatin) in the First Line Treatment in Patients With Metastatic Colorectal Cancer Expressing EGFR or Not

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Time to response [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: September 2005
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the complete response rate in patients with metastatic colorectal cancer treated with cetuximab and FOLFIRINOX chemotherapy comprising oxaliplatin, irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.

Secondary

  • Determine the objective response rate in patients treated with this regimen.
  • Assess the tolerability of this regimen in these patients.
  • Determine the time to response and time to progression in patients treated with this regimen.
  • Determine the survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1 and 8. Patients also receive FOLFIRINOX chemotherapy comprising oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 30-90 minutes, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal cancer

    • Metastatic, unresectable disease
  • May or may not express the EGFR gene
  • Measurable disease, defined as ≥ 1 measurable lesion by MRI or CT scan

    • Lesion must be outside an irradiated area

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Transaminases ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)
  • Creatinine ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No peripheral or symptomatic neuropathy ≥ grade 2 (NCI-CTCAE)
  • No complete or partial intestinal blockage
  • No intestinal inflammatory disease (e.g., Crohn's disease or ulcerative colitis)
  • No chronic diarrhea
  • No severe unstable cardiac disease (despite treatment)
  • No myocardial infarction within the past 6 months
  • No neurological or psychiatric illness, including epilepsy or dementia
  • No uncontrolled active infection
  • No other prior or concurrent malignancy within the past 5 years except for curatively treated basal cell skin cancer
  • No psychological, familial, social, or geographic reason that would preclude study follow-up

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for metastatic disease

    • Prior fluorouracil-based adjuvant chemotherapy allowed provided it was administered ≥ 4 weeks ago
  • At least 4 weeks since prior and no other concurrent experimental therapy
  • No prior irinotecan hydrochloride, oxaliplatin, or monoclonal antibody
  • No prior intestinal resection (e.g., hemicolectomy or extended resection of the small intestine)
  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: NCT00556413

Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
Study Chair: Marc Ychou, MD, PhD Centre Val d'Aurelle - Paul Lamarque
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00556413     History of Changes
Other Study ID Numbers: CDR0000574149, CLCC-ERBIRINOX, INCA-RECF0288, EUDRACT-2005-004746-13, MERCK-CLCC-ERBIRINOX
Study First Received: November 9, 2007
Last Updated: May 13, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

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

ClinicalTrials.gov processed this record on October 23, 2014