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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
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: celecoxib
Drug: docetaxel
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: May 2004
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274898

Locations
France
Hopital Avicenne
Bobigny, France, 93009
Centre Medical de Forcilles Hopital Prive
Ferroles Attilly, France, 77150
Clinique du Petit Colmouilins
Harfleur, France, 76700
Clinique Victor Hugo
Le Mans, France, F-72000
Polyclinique des Quatre Pavillons
Lormont, France, 33310
Centre de Radiotherapie et Oncologie Saint-Faron
Mareuil Les Meaux, France, 77100
American Hospital of Paris
Neuilly Sur Seine, France, F-92202
Clinique De Valdegour
Nimes, France, 30900
Hopital Saint-Louis
Paris, France, 75475
Hopital Tenon
Paris, France, 75970
Clinique les Bleuets
Reims, France, 51100
Polyclinique De Courlancy
Reims, France, F-51100
Clinique Armoricaine De Radiologie
Saint Brieuc, France, F-22015
Centre Hospitalier Sud-Reiunion
Saint Pierre, France, 97448
Clinique Sainte Clotilde
Sainte Clotilde, France, 97192
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Jean F. Morere, MD Hopital Avicenne
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274898     History of Changes
Other Study ID Numbers: CDR0000454352, GERCOR-B03-1, EU-20572, SANOFI-GERCOR-B03-1, PFIZER-GERCOR-B03-1
Study First Received: January 10, 2006
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Celecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014