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Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00274898
First received: January 10, 2006
Last updated: February 6, 2009
Last verified: September 2006

January 10, 2006
February 6, 2009
May 2004
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Time to progression [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00274898 on ClinicalTrials.gov Archive Site
  • 2-year survival rate [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Weight changes [ Designated as safety issue: No ]
  • Objective response [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
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Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer
Phase II Randomized Study Evaluting the Effect of Celecoxib as Maintenance Treatment of Stage IIIb Non-Small Cell Lung Cancer That Reponded or is Stable After Radiochemotherapy

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 cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving celecoxib after radiation therapy and chemotherapy may kill any tumor cells that remain after radiation therapy and chemotherapy. Sometimes, after radiation therapy and chemotherapy, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to observation in treating patients who have undergone radiation therapy and chemotherapy for stage II or stage III non-small cell lung cancer.

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.

Secondary

  • Compare the 2-year survival rate of patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.
  • Compare weight changes and objective response in patients treated with these regimens.
  • Compare tolerability of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2), and total dose of radiotherapy (65 Gy vs 60 Gy).

All patients undergo radiotherapy 5 days a week for 7.5 weeks. Patients also receive docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Three weeks after the completion of radiotherapy, patients receive docetaxel alone IV over 30 minutes on days 1 and 22. Three weeks later, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients are observed every 3 months for 1 year and then every 6 months for 1 year.
  • Arm II: Patients receive oral celecoxib twice daily for up to 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 3 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Interventional
Phase 2
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: celecoxib
  • Drug: docetaxel
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
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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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00274898
CDR0000454352, GERCOR-B03-1, EU-20572, SANOFI-GERCOR-B03-1, PFIZER-GERCOR-B03-1
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Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Not Provided
Study Chair: Jean F. Morere, MD Hopital Avicenne
National Cancer Institute (NCI)
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP