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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: docetaxel; Radiation: radiation therapy; Procedure: adjuvant therapy; Drug: celecoxib

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93009
    • Hopital Avicenne
  • Ferroles Attilly, France, 77150
    • Centre Medical de Forcilles Hopital Prive
  • Harfleur, France, 76700
    • Clinique du Petit Colmouilins
  • Le Mans, France, F-72000
    • Clinique Victor Hugo
  • Lormont, France, 33310
    • Polyclinique des Quatre Pavillons
  • Mareuil Les Meaux, France, 77100
    • Centre de Radiotherapie et Oncologie Saint-Faron
  • Neuilly Sur Seine, France, F-92202
    • American Hospital of Paris
  • Nimes, France, 30900
    • Clinique De Valdegour
  • Paris, France, 75970
    • Hôpital Tenon
  • Paris, France, 75475
    • Hôpital Saint-Louis
  • Reims, France, F-51100
    • Polyclinique de Courlancy
  • Reims, France, 51100
    • Clinique les Bleuets
  • Saint Brieuc, France, F-22015
    • Clinique Armoricaine de Radiologie
  • Saint Pierre, France, 97448
    • Centre Hospitalier Sud-Reiunion
  • Sainte Clotilde, France, 97192
    • Clinique sainte Clotilde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to progression

Secondary Outcome Measures

Outcome Measure
Objective response
Quality of life
Tolerability
2-year survival rate
Weight changes

Collaborators and Investigators

• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
• Investigators: Study Chair: Jean F. Morere, MD, Hopital Avicenne

Study record dates

Study Major Dates

• Study Start: May 1, 2004

Study Registration Dates

• First Submitted: January 10, 2006
• First Submitted That Met QC Criteria: January 10, 2006
• First Posted (Estimate): January 11, 2006

Study Record Updates

• Last Update Posted (Estimate): February 9, 2009
• Last Update Submitted That Met QC Criteria: February 6, 2009
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage II non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Cyclooxygenase 2 Inhibitors; Docetaxel; Celecoxib
• Other Study ID Numbers: CDR0000454352; GERCOR-B03-1; EU-20572; SANOFI-GERCOR-B03-1; PFIZER-GERCOR-B03-1