Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Recruitment status was Active, not recruiting
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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 |
- 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 |
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| 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 | |
| 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 May 22, 2013