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

NCT00030407 | Completed Phase 2

• 4 other identifiers: CDR0000069163P30CA022453WSU-C-2305NCI-V01-1687
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy of combining celecoxib with docetaxel in elderly (> or = 70 yrs old) or poor performance status (PS)of 2

  Blood levels of VEGF \& PGE2

  Weeks 1, 2, and 3

Secondary Outcomes (4)

• Response rate of Celecoxib and Docetaxel

  Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecosxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation.

• Toxicity of Celecoxib and Docetaxel

  Weeks 1, 2, and 3 of each 28 day cycle

• Expression of cyclooxygenase-2 (COX-2) in tumors

  Pre-Study

• Changes in plasma levels of prostaglandin E2(PGE2) & vascular endothelial growth factor (VEGF)

  Pre-study, Weeks 1, 2 and 5

Study Arms (1)

Celecoxib & Docetaxel

EXPERIMENTAL

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.

Drug: Celecoxib; Drug: Docetaxel

Interventions

Celecoxib DRUG

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

Also known as: Celebrex, Celebra

Celecoxib & Docetaxel

Docetaxel 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.

Also known as: Taxotere®

Celecoxib & Docetaxel

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Publications (2)

• 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.

  PMID: 18978565 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Celecoxib; Docetaxel

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

Study Officials

• Shirish M. Gadgeel, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Primary Completion: September 1, 2005
• Study Completion: April 1, 2009
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (1)