Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00274872
First received: January 10, 2006
Last updated: January 29, 2010
Last verified: May 2007
  Purpose

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer that cannot be removed by surgery.


Condition Intervention Phase
Colorectal Cancer
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Time to disease control [ Designated as safety issue: No ]
  • Response as measured by RECIST criteria [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life as assessed by EUROQOL- 5 Dimensional Instrument or Functional Assessment of Cancer Therapy-Neurotoxicity module version 4.0 at baseline and periodically during study treatment [ Designated as safety issue: Yes ]
  • Pharmaco-economic evaluation [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven adenocarcinoma of the colon or rectum

    • Metastatic disease

      • No metastases involving only the bone
  • Inoperable disease (i.e., not suitable for complete surgical resection)
  • Measurable or evaluable disease

    • Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan
  • No symptomatic ascites or pleural effusion that has not been evacuated
  • No CNS metastasis

PATIENT CHARACTERISTICS:

  • WHO OR ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelets ≥ 100,000/mm^3
  • Creatinine < 3 times upper limit of normal (ULN)
  • Alkaline phosphatase < 5 times ULN
  • No peripheral neuropathy ≥ grade 1
  • No total or partial bowel obstruction
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No uncontrolled hypercalcemia
  • No other concurrent or prior malignancy, except adequately treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin or cancer in complete remission for ≥ 5 years
  • No uncontrolled congestive heart failure
  • No angina pectoris
  • No hypertension
  • No arrhythmias
  • No history of significant neurologic or psychiatric disorders
  • No active infection
  • No other serious nonmalignant disease

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy and/or immunotherapy for metastatic disease
  • Prior adjuvant chemotherapy allowed provided progression-free interval after completion of adjuvant chemotherapy is > 6 months
  • No other concurrent anticancer treatment
  • No participation in another clinical trial with any investigational drug within 30 days prior to randomization
  • No other concurrent investigational treatment
  • No concurrent radiotherapy
  • No concurrent cold cap for prevention of alopecia or iced mouth rinses for prevention of stomatitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274872

Locations
France
Hopital Duffaut
Avignon, France, 84902
Institut Sainte Catherine
Avignon, France, 84082
Infirmerie Protestante
Caluire, France, 69300
Hopital Drevon
Dijon, France, 21000
Centre Hospitalier de Dreux
Dreux, France, 28100
Hopital Louis Pasteur - Le Coudray
Le Coudray, France, 28630
Clinique Victor Hugo
Le Mans, France, F-72000
Hopital Robert Boulin
Libourne, France, 33500
Clinique Saint Jean
Lyon, France, 69008
Intercommunal Hospital
Montfermeil, France, 93370
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Polyclinique De Courlancy
Reims, France, F-51100
Clinique des Jockeys
Senlis, France, 60309
C.H. Senlis
Senlis, France, 60309
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Aimery de Gramont, MD Hopital Saint Antoine
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00274872     History of Changes
Other Study ID Numbers: CDR0000453890, GERCOR-OPTIMOX2, GERCOR-OPTIMOX2-2003, GERCOR-OPTIMOX2-C02-2, EU-20566, SANOFI-GERCOR-OPTIMOX2
Study First Received: January 10, 2006
Last Updated: January 29, 2010
Health Authority: United States: Federal Government

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

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
Fluorouracil
Oxaliplatin
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014