Status:
UNKNOWN
Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the...
Detailed Description
OBJECTIVES: Primary * Compare the time to progression in patients with stage II-IIIB non-small cell lung cancer treated with celecoxib vs observation after treatment with chemoradiotherapy. Seconda...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer meeting ≥ 1 of the following criteria:
- Stage IIIB disease
- Stage II or IIIA disease, meeting the following criteria:
- Considered nonresectable
- Pleural effusion present
- Measurable disease
- Must have received a prior regimen of radiotherapy and chemotherapy comprising docetaxel and carboplatin
- Tumor volume must be able to be encompassed in the radiation field
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 12 weeks
- Cardiac function compatible with radiotherapy
- Neutrophil count ≥ 2,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.25 times ULN
- AST and ALT ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Not pregnant or nursing
- No other malignancy in the past 10 years except basal cell skin cancer or carcinoma in situ of the cervix
- No active infection
- No inflammatory bowel disease
- No severe congestive heart failure
- No severe hepatic disease defined as albumin \< 25 g/L or Child-Pugh score ≥ 10
- No severe renal disease defined as creatinine clearance \< 30 mL/min
- No known hypersensitivity to sulfonamides, the study or it's excipients, or polysorbate 80
- No known hypersensitivity of NSAIDs, salicylic acid, or cyclo-oxygenase-2 inhibitors
- No familial, social, geographical, or psychological condition that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 30 days since participation in another clinical study
- More than 1 month since prior therapy for gastrointestinal ulcers
- No concurrent fluconazole, ketoconazole, lithium, or dextromethorphan
- No other concurrent anticancer treatment including chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic response modifier therapy
- No concurrent aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
- Low-dose aspirin or NSAIDs for a duration of ≤ 1 week during the past 3 months allowed
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00274898
Start Date
May 1 2004
Last Update
February 9 2009
Active Locations (15)
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1
Hopital Avicenne
Bobigny, France, 93009
2
Centre Medical de Forcilles Hopital Prive
Ferroles Attilly, France, 77150
3
Clinique du Petit Colmouilins
Harfleur, France, 76700
4
Clinique Victor Hugo
Le Mans, France, F-72000