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Evaluation Of Celecoxib In Combination With Docetaxel In The Treatment Of Advanced Non-Small Cell Lung Cancer Patients Previously Treated With Platinum Based Chemotherapy

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Evaluation Of Celecoxib In Combination With Docetaxel In The Treatment Of Advanced Non-Small Cell Lung Cancer Patients Previously Treated With Platinum Based Chemotherapy


- Determine the efficacy and feasibility of celecoxib combined with docetaxel in patients
with advanced non-small cell lung cancer previously treated with platinum-based

- 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 day 1. Treatment repeats every 21 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

Inclusion Criteria


- Diagnosis of stage IIIA, IIIB, or IV non-small cell lung cancer

- Disease progression during or after 1 or more platinum-based chemotherapy

- 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



- 18 and over

Performance status:

- SWOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8 g/dL


- 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


- Creatinine no greater than ULN


- 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


- No gastrointestinal bleeding within the past 6 months

- No history of peptic ulcer disease


- 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


Biologic therapy:

- Not specified


- 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


- At least 4 weeks since prior radiotherapy

- No prior radiotherapy to target lesion


- At least 4 weeks since prior major surgery


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of combining Celecoxib with Docetaxel

Outcome Description:

Blood levels of VEGF & PGE2

Outcome Time Frame:

Weeks 1 , 2 and 3

Safety Issue:


Principal Investigator

Shirish M. Gadgeel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

October 2001

Completion Date:

February 2008

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201