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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Docetaxel
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Celecoxib & Docetaxel

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy of combining celecoxib with docetaxel in elderly (> or = 70 yrs old) or poor performance status (PS)of 2
Blood levels of VEGF & PGE2

Secondary Outcome Measures

Response rate of Celecoxib and Docetaxel
CT Chest/Abdomen
Toxicity of Celecoxib and Docetaxel
Routine bloodwork
Expression of cyclooxygenase-2 (COX-2) in tumors
Tissue sample from initial diagnosis, parrafin embedded tissue block
Changes in plasma levels of prostaglandin E2(PGE2) & vascular endothelial growth factor (VEGF)
Collecting blood plasma

Full Information

First Posted
February 14, 2002
Last Updated
April 25, 2013
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00030407
Brief Title
Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib & Docetaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex, Celebra
Intervention Description
On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of combining celecoxib with docetaxel in elderly (> or = 70 yrs old) or poor performance status (PS)of 2
Description
Blood levels of VEGF & PGE2
Time Frame
Weeks 1, 2, and 3
Secondary Outcome Measure Information:
Title
Response rate of Celecoxib and Docetaxel
Description
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.
Title
Toxicity of Celecoxib and Docetaxel
Description
Routine bloodwork
Time Frame
Weeks 1, 2, and 3 of each 28 day cycle
Title
Expression of cyclooxygenase-2 (COX-2) in tumors
Description
Tissue sample from initial diagnosis, parrafin embedded tissue block
Time Frame
Pre-Study
Title
Changes in plasma levels of prostaglandin E2(PGE2) & vascular endothelial growth factor (VEGF)
Description
Collecting blood plasma
Time Frame
Pre-study, Weeks 1, 2 and 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirish M. Gadgeel, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18978565
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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

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