Expired Study
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Detroit, Michigan 48201


Purpose:

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.


Study summary:

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


Criteria:

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


Study is Available At:


Original ID:

CDR0000069164


NCT ID:

NCT00030420


Secondary ID:

P30CA022453


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Barbara Ann Karmanos Cancer Institute


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Shirish M. Gadgeel, MD
Study Chair
Barbara Ann Karmanos Cancer Institute

Study Dates

Start Date:October 2001
Completion Date:February 2008
Completion Type:Actual
Primary Completion Date:May 2004
Primary Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 12, 2012
First Received Date:February 14, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:celecoxib
Intervention Type:Drug
Name:docetaxel

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Barbara Ann Karmanos Cancer Institute
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:19057272

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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