Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	WSU-C-2563 ZENECA-1839US/0252, NCT00068653

Objectives

Primary

1. Determine the response rate in patients with platinum-refractory non-small cell lung cancer treated with gefitinib and celecoxib.

Secondary

1. Determine the progression-free and overall survival of patients treated with this regimen.
2. Determine the toxicity of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 18-27 patients will be accrued for this study within 22 months.

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.

Trial Contact Information

Trial Lead Organizations

Barbara Ann Karmanos Cancer Institute

Shirish Gadgeel, MD, Protocol chair		Ph: 313-576-8753; 800-527-6266 Email: gadgeels@karmanos.org

Registry Information
Official Title		Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients with Platinum Refractory Non-Small Cell Lung Cance
Trial Start Date		2003-06-01
Registered in ClinicalTrials.gov		NCT00068653 1
Date Submitted to PDQ		2003-07-30
Information Last Verified		2005-01-06
NCI Grant/Contract Number		P30-CA22453

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00068653