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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00274898
• Other study ID #: CDR0000454352
• Secondary ID: GERCOR-B03-1EU-2
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 10, 2006
• Last updated: February 6, 2009
• Start date: May 2004

Study information

• Verified date: September 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• celecoxib

• docetaxel

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	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 Les Meaux
France	American Hospital of Paris	Neuilly Sur Seine
France	Clinique De Valdegour	Nimes
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

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression			No
Secondary	2-year survival rate			No
Secondary	Quality of life			No
Secondary	Weight changes			No
Secondary	Objective response			No
Secondary	Tolerability			Yes