Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer
NCT ID: NCT00005093
Last Updated: 2012-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1999-12-31
2001-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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gemcitabine hydrochloride
tacedinaline
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Kathryn Kimmel, PhD
Role: STUDY_CHAIR
Pfizer Incorporated - Ann Arbor
Locations
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Cedars-Sinai Comprehensive Cancer Center
Los Angeles, California, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
West Clinic, P.C.
Memphis, Tennessee, United States
Southwest Regional Cancer Center
Austin, Texas, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
BC Cancer Agency
Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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CDR0000067735
Identifier Type: -
Identifier Source: secondary_id
ILEX-994-013
Identifier Type: -
Identifier Source: secondary_id
PD-994-013
Identifier Type: -
Identifier Source: org_study_id