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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
ZD1839
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 recurrent non-small cell lung cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Progression of disease during platinum-based (cisplatin or carboplatin) chemotherapy or within 3 months of completing chemotherapy Treatment with other agents since prior platinum-based chemotherapy allowed Measurable disease Target lesions within a prior radiation field must have documented evidence of progression at least 8 weeks after the completion of radiotherapy No active brain or leptomeningeal metastases Treated brain metastases allowed at least 4 weeks after the completion of appropriate therapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 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 2.5 times ULN (if alkaline phosphatase is no greater than ULN) Alkaline phosphatase no greater than 5 times ULN (if AST and ALT are greater than ULN) No history of chronic hepatitis Renal Creatinine no greater than 1.5 times ULN Cardiovascular No active thromboembolic event within the past 4 weeks No uncontrolled congestive heart failure No uncontrolled angina No myocardial infarction and/or stroke within the past 6 months Pulmonary No evidence of clinically active interstitial lung disease Gastrointestinal No history of gastrointestinal bleeding within the past 6 months No history of peptic ulcer disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must weigh at least 110 pounds (50 kg) HIV negative No allergy to sulfonamides No allergy to any NSAID, including celecoxib No known severe hypersensitivity to gefitinib or any of its excipients No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of dementia, active psychiatric disorder, or any other condition that would preclude study compliance No other concurrent serious medical condition PRIOR CONCURRENT THERAPY: Biologic therapy No prior epidermal growth factor receptor inhibitor No concurrent biologic therapy Chemotherapy See Disease Characteristics More than 2 weeks since prior chemotherapy Endocrine therapy Not specified Radiotherapy Recovered from prior radiotherapy Surgery Recovered from prior surgery Other Recovered from prior therapy More than 2 weeks since prior investigational therapy More than 1 week since prior fluconazole More than 30 days since prior participation in another investigational agent clinical trial More than 30 days since prior chronic nonsteroidal anti-inflammatory drugs (NSAIDs), including celecoxib or rofecoxib No prior gefitinib No prior cyclooxygenase-2 (COX-2) inhibitor or another clinical trial for NSCLC No other concurrent NSAIDs Concurrent aspirin allowed (not to exceed 325 mg/day) No other concurrent COX-2 inhibitors No concurrent lithium No concurrent fluconazole No concurrent use of any of the following: Phenytoin Carbamazepine Barbiturates Rifampin Phenobarbital Hypericum perforatum

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Celecoxib & ZD1839

Arm Description

Celecoxib: 400mg orally two times a day, taken with meals. ZD1839: 250 mg po every day, taken with or without food.

Outcomes

Primary Outcome Measures

Response rate
CT scan chest/abdomen; Assessments of complete response (CR) or partial response (PR)require confirmation 4 weeks or later.

Secondary Outcome Measures

Progression-free survival (PFS)
Overall survival
Toxicity of this drug combination

Full Information

First Posted
September 10, 2003
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
NCT00068653
Brief Title
Gefitinib and Celecoxib in Treating Patients With Refractory Non-Small Cell Lung Cancer
Official Title
Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
May 2008 (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
Yes

5. Study Description

Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Combining gefitinib with celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with celecoxib in treating patients who have non-small cell lung cancer that is refractory to platinum-based chemotherapy (such as cisplatin or carboplatin).
Detailed Description
OBJECTIVES: Primary Determine the response rate in patients with platinum-refractory non-small cell lung cancer treated with gefitinib and celecoxib. Secondary Determine the progression-free and overall survival of patients treated with this regimen. Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive oral gefitinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for up to 6 weeks. PROJECTED ACCRUAL: A total of 18-27 patients will be accrued for this study within 22 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent 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
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib & ZD1839
Arm Type
Experimental
Arm Description
Celecoxib: 400mg orally two times a day, taken with meals. ZD1839: 250 mg po every day, taken with or without food.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
Celecoxib 400mg orally two times a day, taken with meals.
Intervention Type
Drug
Intervention Name(s)
ZD1839
Other Intervention Name(s)
Iressa, Gefitinib
Intervention Description
ZD1839 250 mg po every day, taken with or without food.
Primary Outcome Measure Information:
Title
Response rate
Description
CT scan chest/abdomen; Assessments of complete response (CR) or partial response (PR)require confirmation 4 weeks or later.
Time Frame
Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
Title
Overall survival
Time Frame
Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
Title
Toxicity of this drug combination
Time Frame
Every 2 weeks; Every month after 4 cycles if the patient has not developed > Grade 2 toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Progression of disease during platinum-based (cisplatin or carboplatin) chemotherapy or within 3 months of completing chemotherapy Treatment with other agents since prior platinum-based chemotherapy allowed Measurable disease Target lesions within a prior radiation field must have documented evidence of progression at least 8 weeks after the completion of radiotherapy No active brain or leptomeningeal metastases Treated brain metastases allowed at least 4 weeks after the completion of appropriate therapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 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 2.5 times ULN (if alkaline phosphatase is no greater than ULN) Alkaline phosphatase no greater than 5 times ULN (if AST and ALT are greater than ULN) No history of chronic hepatitis Renal Creatinine no greater than 1.5 times ULN Cardiovascular No active thromboembolic event within the past 4 weeks No uncontrolled congestive heart failure No uncontrolled angina No myocardial infarction and/or stroke within the past 6 months Pulmonary No evidence of clinically active interstitial lung disease Gastrointestinal No history of gastrointestinal bleeding within the past 6 months No history of peptic ulcer disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must weigh at least 110 pounds (50 kg) HIV negative No allergy to sulfonamides No allergy to any NSAID, including celecoxib No known severe hypersensitivity to gefitinib or any of its excipients No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of dementia, active psychiatric disorder, or any other condition that would preclude study compliance No other concurrent serious medical condition PRIOR CONCURRENT THERAPY: Biologic therapy No prior epidermal growth factor receptor inhibitor No concurrent biologic therapy Chemotherapy See Disease Characteristics More than 2 weeks since prior chemotherapy Endocrine therapy Not specified Radiotherapy Recovered from prior radiotherapy Surgery Recovered from prior surgery Other Recovered from prior therapy More than 2 weeks since prior investigational therapy More than 1 week since prior fluconazole More than 30 days since prior participation in another investigational agent clinical trial More than 30 days since prior chronic nonsteroidal anti-inflammatory drugs (NSAIDs), including celecoxib or rofecoxib No prior gefitinib No prior cyclooxygenase-2 (COX-2) inhibitor or another clinical trial for NSCLC No other concurrent NSAIDs Concurrent aspirin allowed (not to exceed 325 mg/day) No other concurrent COX-2 inhibitors No concurrent lithium No concurrent fluconazole No concurrent use of any of the following: Phenytoin Carbamazepine Barbiturates Rifampin Phenobarbital Hypericum perforatum
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

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

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