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

NCT00030420 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000069164P30CA022453WSU-C-2304NCI-V01-1688
• Study Type: interventional
• Target: 24
• 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 with celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and docetaxel in treating patients who have advanced non-small cell lung cancer that has been previously treated with platinum-based chemotherapy.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIA non-small cell lung cancer; 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

  Blood levels of VEGF \& PGE2

  Weeks 1 , 2 and 3

Secondary Outcomes (5)

• Response rate of Celecoxib and Docetaxel

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

• Toxicity of Celecoxib and Docetaxel

  Every week

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

  Pre-study

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

  Pre-study; Weeks 1 , 2 and 3

• Vascular changes induced in the tumor by celecoxib

  Weeks 1, 3 & 6

Study Arms (1)

Celecoxib & Docetaxel

EXPERIMENTAL

Celecoxib: 400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment. Doctaxel: Day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days

Drug: Celecoxib; Drug: Docetaxel

Interventions

Celecoxib DRUG

400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.

Also known as: Celebrex, Celebra, Onsenal

Celecoxib & Docetaxel

Docetaxel DRUG

On day 1, 75mg/m2 IV over 60 minutes, repeated every 21 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 stage IIIA, IIIB, or IV non-small cell lung cancer * Disease progression during or after 1 or more platinum-based chemotherapy regimens * 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: * 18 and over Performance status: * 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 of any duration Renal: * Creatinine no greater than 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 active infection * 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: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * Prior paclitaxel allowed * No prior docetaxel 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 other 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 (1)

• Schneider BJ, Kalemkerian GP, Kraut MJ, Wozniak AJ, Worden FP, Smith DW, Chen W, Gadgeel SM. Phase II study of celecoxib and docetaxel in non-small cell lung cancer (NSCLC) patients with progression after platinum-based therapy. J Thorac Oncol. 2008 Dec;3(12):1454-9. doi: 10.1097/JTO.0b013e31818de1d2.

  PMID: 19057272 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: October 21, 2003
• Study Start: October 1, 2001
• Primary Completion: May 1, 2004
• Study Completion: February 1, 2008
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (1)