Colorectal CancerPhase 2NCT00072553
Celecoxib, Leucovorin, Fluorouracil, and Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
A Phase 2 study testing celecoxib, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- celecoxib, fluorouracil and leucovorin calcium
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Sep 2003to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Being tested
- celecoxib, fluorouracil, leucovorin calcium, oxaliplatin, adjuvant therapy
- Keywords
- stage IV rectal cancer, stage IV colon cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent rectal cancer, recurrent colon cancer
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
fluorouracilDrug
oxaliplatinDrug
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Secondary outcomes (6)
Toxicity
Time of disease control (progression-free survival)
Salvage surgery rate
Duration of chemotherapy-free intervals
Tolerability
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2003 (estimated)
- Study startSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Investigators
- Thierry Andre, MD, Study chair, GERCOR - Multidisciplinary Oncology Cooperative Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072553
- Sponsor's protocol ID
- CDR0000340181
- Other IDs
- GERCOR-OPTIMOX2-CELECOXIB-2002, EU-20325
- Status last verified
- May 2007
- First submitted
- 4 Nov 2003
- Last updated
- 9 Feb 2009
- Results posted
- No
Publications
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.
PubMed 17030548
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study
- ClinicalTrials.gov ID
- NCT00072553
- Acronym / sponsor ID
- CDR0000340181
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Sep 2003
- First posted
- 5 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxib | Drug | – |
| fluorouracil | Drug | – |
| leucovorin calcium | Drug | – |
| oxaliplatin | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
Primary outcome
Response rate
6 secondary outcomes
Toxicity
Time of disease control (progression-free survival)
Salvage surgery rate
Duration of chemotherapy-free intervals
Tolerability
Quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
- Results publication: PubMed 17030548Andre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Andre, MD study chair
GERCOR - Multidisciplinary Oncology Cooperative Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing celecoxib, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00072553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2009.