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

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ClinicalTrials.gov Identifier: NCT00030407
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 29, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Celecoxib Drug: Docetaxel Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation Of Celecoxib In Combination With Weekly Docetaxel In Elderly (70 Years) Or Poor Performance Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : October 2001
Actual Primary Completion Date : September 2005
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 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.

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

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.
Other Name: Taxotere®




Primary Outcome Measures :
  1. Efficacy of combining celecoxib with docetaxel in elderly (> or = 70 yrs old) or poor performance status (PS)of 2 [ Time Frame: Weeks 1, 2, and 3 ]
    Blood levels of VEGF & PGE2


Secondary Outcome Measures :
  1. Response rate of Celecoxib and Docetaxel [ Time Frame: 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. ]
    CT Chest/Abdomen

  2. Toxicity of Celecoxib and Docetaxel [ Time Frame: Weeks 1, 2, and 3 of each 28 day cycle ]
    Routine bloodwork

  3. Expression of cyclooxygenase-2 (COX-2) in tumors [ Time Frame: Pre-Study ]
    Tissue sample from initial diagnosis, parrafin embedded tissue block

  4. Changes in plasma levels of prostaglandin E2(PGE2) & vascular endothelial growth factor (VEGF) [ Time Frame: Pre-study, Weeks 1, 2 and 5 ]
    Collecting blood plasma



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030407


Locations
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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
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Study Chair: Shirish M. Gadgeel, MD Barbara Ann Karmanos Cancer Institute

Publications of Results:
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.

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Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00030407     History of Changes
Other Study ID Numbers: CDR0000069163
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-C-2305 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
NCI-V01-1687
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013
Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Additional relevant MeSH terms:
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Celecoxib
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors