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

NCT00274898 | Unknown Phase 2

• 5 other identifiers: CDR0000454352GERCOR-B03-1EU-20572SANOFI-GERCOR-B03-1PFIZER-GERCOR-B03-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 15

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to progression

Secondary Outcomes (5)

• 2-year survival rate

• Quality of life

• Weight changes

• Objective response

• Tolerability

Interventions

celecoxib DRUG

docetaxel DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (15)

Hopital Avicenne

Bobigny, 93009, France

Location

Centre Medical de Forcilles Hopital Prive

Ferroles Attilly, 77150, France

Location

Clinique du Petit Colmouilins

Harfleur, 76700, France

Location

Clinique Victor Hugo

Le Mans, F-72000, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

Centre de Radiotherapie et Oncologie Saint-Faron

Mareuil-lès-Meaux, 77100, France

Location

American Hospital of Paris

Neuilly-sur-Seine, F-92202, France

Location

Clinique De Valdegour

Nîmes, 30900, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Tenon

Paris, 75970, France

Location

Clinique les Bleuets

Reims, 51100, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Hospitalier Sud-Reiunion

Saint-Pierre, 97448, France

Location

Clinique Sainte Clotilde

Sainte Clotilde, 97192, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Celecoxib; Docetaxel; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Jean F. Morere, MD

  Hopital Avicenne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: May 1, 2004
• Last Updated: February 9, 2009

Record last verified: 2006-09

Locations

FR (15)