Celecoxib, Leucovorin, Fluorouracil, and Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

NCT00072553 | Unknown Phase 2

• 3 other identifiers: CDR0000340181GERCOR-OPTIMOX2-CELECOXIB-2002EU-20325
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining celecoxib with leucovorin, fluorouracil, and oxaliplatin in treating patients who have metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response rate

Secondary Outcomes (6)

• Toxicity

• Time of disease control (progression-free survival)

• Salvage surgery rate

• Duration of chemotherapy-free intervals

• Tolerability

Interventions

celecoxib DRUG

fluorouracil DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Metastatic disease * Inoperable disease (i.e., not suitable for complete carcinological surgical resection) * Measurable disease or nonmeasurable disease * At least 1 unidimensionally measurable lesion at least 20 mm by conventional CT scan OR 10 mm by spiral CT scan * Nonmeasurable disease defined as all other lesions, including small lesions or truly nonmeasurable disease * No CNS metastases * No exclusive bone metastases * No symptomatic ascites or pleural effusion not evacuated before study entry PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No known significant bleeding disorder Hepatic * Alkaline phosphatase less than 3 times upper limit of normal (ULN) Renal * Creatinine less than 1.5 times ULN OR * Creatinine clearance at least 30 mL/min * No uncontrolled hypercalcemia Cardiovascular * No congestive heart failure Gastrointestinal * No total or partial bowel obstruction * No active gastric or duodenal ulceration or gastrointestinal bleeding within the past year * No active inflammatory bowel disease Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No peripheral sensory neuropathy * No known sensitivity to celecoxib, other COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides * No AIDS-related illness * No active infection * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for metastatic disease Chemotherapy * Prior adjuvant chemotherapy allowed provided the progression-free interval after completion of therapy is more than 6 months in duration * No prior chemotherapy for metastatic disease * No prior adjuvant oxaliplatin * No other concurrent chemotherapy Endocrine therapy * No concurrent chronic oral or IV corticosteroid use (i.e., 2 weeks or longer in duration) Radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * More than 30 days since prior investigational drugs * No other concurrent investigational drugs or treatments * No concurrent prophylactic fluconazole * No concurrent chronic full-dose aspirin (at least 325 mg/day), other nonsteroidal anti-inflammatory drugs (NSAIDs), or other cyclooxygenase (COX)-2 inhibitors * Concurrent low-dose (cardioprotective) aspirin (80 mg/day or equivalent) allowed * No concurrent lithium * No other concurrent anticancer therapy

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 (1)

Hopital Tenon

Paris, 75970, France

Location

Related Publications (1)

• Andre T, Tournigand C, Mineur L, Fellague-Chebra R, Flesch M, Mabro M, Hebbar M, Postel Vinay S, Bidard FC, Louvet C, de Gramont A. Phase II study of an optimized 5-fluorouracil-oxaliplatin strategy (OPTIMOX2) with celecoxib in metastatic colorectal cancer: a GERCOR study. Ann Oncol. 2007 Jan;18(1):77-81. doi: 10.1093/annonc/mdl336. Epub 2006 Oct 9.

  PMID: 17030548 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms

Interventions

Celecoxib; Fluorouracil; Leucovorin; Oxaliplatin; Chemotherapy, Adjuvant; Neoadjuvant Therapy

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)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Thierry Andre, MD

  GERCOR - Multidisciplinary Oncology Cooperative Group

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 5, 2003
• Study Start: September 1, 2003
• Last Updated: February 9, 2009

Record last verified: 2007-05

Locations

FR (1)