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

Information source: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: Celecoxib (Drug); ZD1839 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Barbara Ann Karmanos Cancer Institute

Official(s) and/or principal investigator(s):
Shirish M. Gadgeel, MD, Study Chair, Affiliation: Barbara Ann Karmanos Cancer Institute


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).

Clinical Details

Official title: Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance

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

Primary outcome: Response rate

Secondary outcome:

Progression-free survival (PFS)

Overall survival

Toxicity of this drug combination

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


- 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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


- 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 2. 5 times ULN (if alkaline phosphatase is no greater than


- Alkaline phosphatase no greater than 5 times ULN (if AST and ALT are greater than


- No history of chronic hepatitis


- Creatinine no greater than 1. 5 times ULN


- 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


- No evidence of clinically active interstitial lung disease


- No history of gastrointestinal bleeding within the past 6 months

- No history of peptic ulcer disease


- 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


- No prior epidermal growth factor receptor inhibitor

- No concurrent biologic therapy


- See Disease Characteristics

- More than 2 weeks since prior chemotherapy

Endocrine therapy

- Not specified


- Recovered from prior radiotherapy


- Recovered from prior surgery


- 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


- 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

Locations and Contacts

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 2003
Last updated: April 25, 2013

Page last updated: August 23, 2015

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