Lung Cancer Clinical Trial

Gemcitabine With or Without CI-994 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. It is not yet known whether gemcitabine plus CI-994 is more effective than gemcitabine alone for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced non-small cell lung cancer.

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Full Description

OBJECTIVES: I. Determine the efficacy and safety of gemcitabine with or without CI-994 in patients with advanced non-small cell lung cancer.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to performance status and are randomized to one of two treatment arms. Arm I: Patients receive CI-994 orally on days 1-21 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Arm II: Patients receive placebo capsules orally on days 1-21 and gemcitabine as in arm I. Treatment repeats every 28 days as long as medically appropriate (absence of disease progression or unacceptable toxicity).

PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.

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Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent, locally advanced, or metastatic, unresectable non-small cell lung cancer Failed or relapsed after one prior platinum containing regimen (cisplatin or carboplatin) as first line therapy Prior brain metastases allowed if resection and/or radiotherapy completed, no worsening of CNS symptoms, and at least 1 month since prior corticosteroids

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (no greater than 5 times ULN in patients with liver metastases) Renal: Creatinine clearance at least 50 mL/min Other: Able to swallow intact study capsules No active infection No life threatening illness (other than tumor) No prior malignancy within the past 5 years except well controlled nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No more than one prior regimen of chemotherapy No prior gemcitabine No prior CI-994 At least 4 weeks since prior maintenance or consolidation therapy (e.g., matrix metalloprotein inhibitors) Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy to primary site Surgery: Not specified

Study is for people with:

Lung Cancer

Phase:

Phase 3

Study ID:

NCT00005093

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 16 Locations for this study

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Cedars-Sinai Comprehensive Cancer Center
Los Angeles California, 90048, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
New England Medical Center Hospital
Boston Massachusetts, 02111, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh North Carolina, 27609, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
West Clinic, P.C.
Memphis Tennessee, 38117, United States
Southwest Regional Cancer Center
Austin Texas, 78705, United States
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey British Columbia, V3V 1, Canada
BC Cancer Agency
Vancouver British Columbia, V5Z 4, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria British Columbia, V8R 1, Canada
Ottawa Regional Cancer Center - General Division
Ottawa Ontario, K1H 8, Canada
Mount Sinai Hospital - Toronto
Toronto Ontario, M5G 1, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Study ID:

NCT00005093

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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