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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate

Outcome Description:

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

Outcome Time Frame:

Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation

Safety Issue:

No

Principal Investigator

Shirish M. Gadgeel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000327805

NCT ID:

NCT00068653

Start Date:

June 2003

Completion Date:

May 2008

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201