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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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (15 locations)

    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