Clinical trial NCT00005093: Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer
Official title: A Randomized Double-Blind, Placebo-Controlled, Multicenter Study of CI-994 Capsules Plus Gemcitabine Infusion Versus Placebo Capsules Plus Gemcitabine Infusion as Second-Line Treatment of Patients With Advanced Nonsmall Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-06-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Comprehensive Cancer Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Boston
country: United States
facility: New England Medical Center Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Raleigh
country: United States
facility: Raleigh Hematology/Oncology Associates - Wake Practice
state: North Carolina
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital - Ohio State University
state: Ohio
city: Memphis
country: United States
facility: West Clinic, P.C.
state: Tennessee
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Surrey
country: Canada
facility: British Columbia Cancer Agency - Fraser Valley Cancer Centre
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
city: Victoria
country: Canada
facility: British Columbia Cancer Agency - Vancouver Island Cancer Centre
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Center - General Division
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital - Toronto
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Pfizer Incorporated - Ann Arbor
name: Kathryn Kimmel, PhD
role: STUDY_CHAIR
References: