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CompletedNCT00030407Updated Apr 29, 2013

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

A Phase 2 interventional study of Celecoxib and Docetaxel in Lung Cancer, sponsored by Barbara Ann Karmanos Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-29.

Sponsored by Barbara Ann Karmanos Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer

Keywords

  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 34 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • 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 · Drug: Docetaxel

Interventions

  • DrugCelecoxib

    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

  • DrugDocetaxel

    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®

06

What researchers measure

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

    Time frame: Weeks 1, 2, and 3

Secondary outcomes

  1. Response rate of Celecoxib and Docetaxel

    CT Chest/Abdomen

    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.

  2. Toxicity of Celecoxib and Docetaxel

    Routine bloodwork

    Time frame: Weeks 1, 2, and 3 of each 28 day cycle

  3. Expression of cyclooxygenase-2 (COX-2) in tumors

    Tissue sample from initial diagnosis, parrafin embedded tissue block

    Time frame: Pre-Study

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

    Collecting blood plasma

    Time frame: Pre-study, Weeks 1, 2 and 5

07

Study locations

1 site
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201-1379, United States
08

References and documents

Publications

  • 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. PubMed 18978565 ↗
  • 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.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00030407
Lead sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Oct 2001
Primary completion
Sep 2005
Completion
Apr 2009
Last update
Apr 29, 2013

Study contacts

Shirish M. Gadgeel, MD
study chair · Barbara Ann Karmanos Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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