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

NCT00274872 | Unknown Phase 2

• 6 other identifiers: CDR0000453890GERCOR-OPTIMOX2GERCOR-OPTIMOX2-2003GERCOR-OPTIMOX2-C02-2EU-20566SANOFI-GERCOR-OPTIMOX2
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

recurrent rectal cancer; stage IV rectal cancer; recurrent colon cancer; stage IV colon cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (6)

• Overall survival

• Time to disease control

• Response as measured by RECIST criteria

• Toxicity

• 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

• Pharmaco-economic evaluation

Interventions

fluorouracil DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (17)

Institut Sainte Catherine

Avignon, 84082, France

Location

Hopital Duffaut

Avignon, 84902, France

Location

Infirmerie Protestante

Caluire-et-Cuire, 69300, France

Location

Hopital Drevon

Dijon, 21000, France

Location

Centre Hospitalier de Dreux

Dreux, 28100, France

Location

Hopital Louis Pasteur - Le Coudray

Le Coudray, 28630, France

Location

Clinique Victor Hugo

Le Mans, F-72000, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Clinique Saint Jean

Lyon, 69008, France

Location

Intercommunal Hospital

Montfermeil, 93370, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Clinique des Jockeys

Senlis, 60309, France

Location

Centre Medico-Chirurgical Foch

Suresnes, 92151, France

Location

Related Publications (1)

• Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, Andre T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.

  PMID: 19786657 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

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)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Aimery de Gramont, MD

  Hopital Saint Antoine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: January 1, 2004
• Last Updated: February 1, 2010

Record last verified: 2007-05

Locations

FR (17)