Lung Cancer Clinical Trial

Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Combining celecoxib with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan and docetaxel when given together with celecoxib and to see how well they work in treating patients with advanced non-small cell lung cancer.

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Full Description

OBJECTIVES:

Determine the recommended phase II dose of docetaxel and irinotecan in combination with celecoxib in patients with advanced non-small cell lung cancer.
Determine the toxic effects of this regimen in these patients.
Determine the response rate of patients treated with this regimen.
Determine the progression-free and overall survival of patients treated with this regimen.
Determine the pharmacokinetics of this regimen in these patients.
Correlate angiogenesis markers (intratumoral microvessel density and vascular endothelial growth factor [VEGF] expression and serum VEGF) and cyclooxygenase-2 expression with response and survival in patients treated with this regimen.
Correlate UGT1A1 genotype and CYP3A4 activity with the toxic effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study of docetaxel and irinotecan.

Phase I: Patients receive docetaxel IV over 60 minutes and irinotecan IV over 30 minutes on days 1 and 8. Patients also receive oral celecoxib twice daily beginning on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of docetaxel and irinotecan until the recommended phase II dose is determined. The recommended phase II dose is defined as the highest dose at which 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.
Phase II: Patients receive treatment as in phase I at the recommended phase II dose.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 3-70 patients (3-36 for phase I and 16-34 for phase II) will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

Stage IV
Stage IIIB with a malignant pleural effusion
Locally recurrent and/or persistent disease after locoregional therapy with or without systemic chemotherapy

Unidimensionally measurable disease

If the only site of measurable disease is in a previously irradiated area must have documented progression of disease in that area
No CNS metastases

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

Hepatic

Bilirubin normal
AST and ALT less than 2.5 times upper limit of normal (ULN) (if alkaline phosphatase is normal)
Alkaline phosphatase less than 4 times ULN (if AST and ALT are normal)

Renal

Creatinine less than 2.0 mg/dL

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study treatment
No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days
No prior hypersensitivity to cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, sulfonamides, or drugs formulated with polysorbate 80
No pre-existing grade 2 or greater peripheral neuropathy
No concurrent medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

At least 1 week since prior biologic therapy

Phase I patients:

Any number of prior biologic therapies allowed (e.g., chimeric antibodies or kinase inhibitors)

Phase II patients:

No prior biologic therapy for recurrent/metastatic disease
No concurrent filgrastim (G-CSF)

Chemotherapy

See Disease Characteristics
At least 4 weeks since prior chemotherapy
No prior irinotecan or docetaxel

Phase I patients:

Up to 2 prior chemotherapy regimens for recurrent/metastatic disease allowed (chemonaïve patients are also eligible)

Phase II patients:

At least 1 year since prior adjuvant or neoadjuvant chemotherapy for stage I-IIIA disease
No prior chemotherapy for recurrent/metastatic disease

Endocrine therapy

Less than 2 weeks of cumulative oral/IV corticosteroid use within the past 3 months

Radiotherapy

See Disease Characteristics
Recovered from prior radiotherapy
At least 3 weeks since prior extensive-field radiotherapy for recurrent/metastatic disease

Surgery

Recovered from prior surgery

Other

More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis
No prior NSAIDs at a frequency of more than 3 times per week for a cumulative period of more than 2 weeks within the past 30 days
No concurrent antiepileptics, cyclosporine, aspirin, or fluconazole
No concurrent NSAIDs
No other concurrent COX-2 inhibitors

Study is for people with:

Lung Cancer

Phase:

Phase 1

Study ID:

NCT00073866

Recruitment Status:

Completed

Sponsor:

Northwestern University

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There are 3 Locations for this study

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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston Illinois, 60201, United States
Silver Cross Hospital
Joliet Illinois, 60432, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Study ID:

NCT00073866

Recruitment Status:

Completed

Sponsor:


Northwestern University

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