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

NCT ID: NCT00274898

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31

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 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.

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

celecoxib

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Principal Investigators

Jean F. Morere, MD

Role: STUDY_CHAIR

Hopital Avicenne

Locations

Hopital Avicenne

Bobigny, , France

Centre Medical de Forcilles Hopital Prive

Ferroles Attilly, , France

Clinique du Petit Colmouilins

Harfleur, , France

Clinique Victor Hugo

Le Mans, , France

Polyclinique des Quatre Pavillons

Lormont, , France

Centre de Radiotherapie et Oncologie Saint-Faron

Mareuil-lès-Meaux, , France

American Hospital of Paris

Neuilly-sur-Seine, , France

Clinique De Valdegour

Nîmes, , France

Hopital Saint-Louis

Paris, , France

Hopital Tenon

Paris, , France

Clinique les Bleuets

Reims, , France

Polyclinique De Courlancy

Reims, , France

Clinique Armoricaine De Radiologie

Saint-Brieuc, , France

Centre Hospitalier Sud-Reiunion

Saint-Pierre, , France

Clinique Sainte Clotilde

Sainte Clotilde, , France

Countries

France

Other Identifiers

GERCOR-B03-1

Identifier Type: -

Identifier Source: secondary_id

EU-20572

Identifier Type: -

Identifier Source: secondary_id

SANOFI-GERCOR-B03-1

Identifier Type: -

Identifier Source: secondary_id

PFIZER-GERCOR-B03-1

Identifier Type: -

Identifier Source: secondary_id

CDR0000454352

Identifier Type: -

Identifier Source: org_study_id