Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

NCT ID: NCT00030407

Last Updated: 2013-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2009-04-30

Brief Summary

RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of celecoxib and docetaxel in treating patients who have non-small cell lung cancer.

Detailed Description

OBJECTIVES:

• Determine the efficacy and feasibility of celecoxib combined with docetaxel as first-line therapy in elderly or poor performance status patients with advanced non-small cell lung cancer.
• Determine the response rate of patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses after CR. Patients who achieve stable disease (SD) or a partial response (PR) receive a minimum of 2 additional courses after SD or PR. At the discretion of the treating physician, patients then receive maintenance therapy comprising celecoxib only.

Patients who discontinue therapy for disease progression or unacceptable toxicity are followed for at least 6 months.

PROJECTED ACCRUAL: A total of 21-39 patients will be accrued for this study within 13-28 months.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Celecoxib & Docetaxel

Celecoxib: On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals

Docetaxel: On day 1, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days.

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals

Docetaxel

Intervention Type: DRUG

On day 1, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days.

Interventions

Celecoxib

On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals

Intervention Type: DRUG

Docetaxel

On day 1, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days.

Intervention Type: DRUG

Other Intervention Names

Celebrex; Celebra; Taxotere®

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of non-small cell lung cancer (NSCLC)

• Stage IIIB with pleural effusion or stage IV disease
• Age 70 years and over with SWOG performance status 0-2 OR age 18 to 69 with SWOG performance status 2
• Measurable or evaluable disease
• No symptomatic or untreated brain or leptomeningeal metastases

• Previously treated patients must be neurologically stable for 4 weeks after completion of appropriate therapy

PATIENT CHARACTERISTICS:

Age:

• See Disease Characteristics
• 18 and over

Performance status:

• See Disease Characteristics
• SWOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 8 g/dL

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)
• AST/ALT no greater than ULN (or no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN)
• Alkaline phosphatase no greater than ULN (or no greater than 5 times ULN if AST/ALT no greater than ULN)
• No history of chronic hepatitis

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled congestive heart failure
• No uncontrolled angina
• No myocardial infarction and/or stroke within the past 6 months
• No active thromboembolic event within the past 4 weeks

Gastrointestinal:

• No gastrointestinal bleeding within the past 6 months
• No history of peptic ulcer disease

Other:

• No prior hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
• No prior allergy to any non-steroidal anti-inflammatory drug
• No other prior or concurrent malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
• No grade 2 or greater peripheral neuropathy
• No other serious concurrent medical illness
• No history of dementia, active psychiatric disorder, or other condition that would interfere with ability to take oral medication or preclude compliance with study
• HIV negative
• Must weigh at least 50 kg (110 pounds)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy for NSCLC

Chemotherapy:

• No prior chemotherapy for NSCLC

Endocrine therapy:

• At least 3 days since prior steroids

Radiotherapy:

• At least 4 weeks since prior radiotherapy
• No prior radiotherapy to target lesion

Surgery:

• At least 4 weeks since prior major surgery

Other:

• Prior intermittent use of non-steroidal anti-inflammatory drugs (NSAIDs), including rofecoxib or celecoxib, allowed
• At least 1 week since prior fluconazole
• No recent prior NSAIDs, including rofecoxib or celecoxib, for a duration of more than 30 consecutive days
• No concurrent fluconazole or lithium
• No concurrent NSAIDs except aspirin administered at a dose of no more than 325 mg/day for cardiovascular conditions
• No other concurrent cyclo-oxygenase-2 inhibitors
• No other concurrent investigational agents

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shirish M. Gadgeel, MD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

References

Gadgeel SM, Wozniak A, Ruckdeschel JC, Heilbrun LK, Venkatramanamoorthy R, Chaplen RA, Kraut MJ, Kalemkerian GP. Phase II study of docetaxel and celecoxib, a cyclooxygenase-2 inhibitor, in elderly or poor performance status (PS2) patients with advanced non-small cell lung cancer. J Thorac Oncol. 2008 Nov;3(11):1293-300. doi: 10.1097/JTO.0b013e31818b194e.

Reference Type: RESULT

PMID: 18978565 (View on PubMed)

Gadgeel SM, Shehadeh N, Kraut MJ, et al.: Preliminary results of a phase II study of celecoxib and weekly docetaxel in elderly (>70 yrs) or PS2 patients with advanced non-small cell lung cancer (NSCLC). [Abstract] Lung Cancer 41 (Suppl 2): A-O-110, S35, 2003.

Reference Type: RESULT

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-C-2305

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-V01-1687

Identifier Type: -

Identifier Source: secondary_id

CDR0000069163

Identifier Type: -

Identifier Source: org_study_id