Suspended

A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study

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What is being tested

Data Collection

Who is being recruted

Colonic Diseases
+8

+ Digestive System Diseases
+ Digestive System Neoplasms
From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the response rate in patients with metastatic colorectal cancer treated with celecoxib, leucovorin calcium, fluorouracil, and oxaliplatin. Secondary * Determine the toxicity of this regimen in these patients. * Determine the time of disease control to evaluate progression-free survival in patients treated with this regimen. * Determine the salvage surgery rate in patients treated with this regimen. * Determine the duration of chemotherapy-free intervals in patients treated with this regimen. * Determine the tolerability of this regimen in these patients. * Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive FOLFOX7 chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. Patients also receive oral celecoxib twice daily beginning on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease stop treatment. If disease progression occurs during the chemotherapy-free interval, patients receive an additional 6 courses. Patients with responding disease after receiving at least 6 courses of chemotherapy may undergo surgery. Beginning within 10 weeks after surgery, patients receive simplified LV5FU2 chemotherapy comprising leucovorin calcium IV over 2 hours on day 1, fluorouracil IV over 46 hours beginning on day 1, and oral celecoxib twice daily beginning on day 1. Treatment repeats every 14 days for at least 12 courses. Quality of life is assessed at baseline, during courses 4 and 6, and then every 2 months thereafter. Patients are followed at 1 month and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Official TitleA Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study 
NCT00072553
Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Colorectal Neoplasms
Criteria

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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Hopital TenonParis, FranceSee the location

SuspendedOne Study Center
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