Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005093
• Other study ID #: PD-994-013
• Secondary ID: CDR0000067735ILE
• Status: Completed
• Phase: Phase 3
• First received: April 6, 2000
• Last updated: August 8, 2012
• Start date: December 1999
• Est. completion date: May 2001

Study information

• Verified date: August 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• tacedinaline

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Ottawa Regional Cancer Center - General Division	Ottawa	Ontario
Canada	British Columbia Cancer Agency - Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	Mount Sinai Hospital - Toronto	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	BC Cancer Agency	Vancouver	British Columbia
Canada	British Columbia Cancer Agency - Vancouver Island Cancer Centre	Victoria	British Columbia
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Southwest Regional Cancer Center	Austin	Texas
United States	New England Medical Center Hospital	Boston	Massachusetts
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Cedars-Sinai Comprehensive Cancer Center	Los Angeles	California
United States	West Clinic, P.C.	Memphis	Tennessee
United States	Raleigh Hematology/Oncology Associates - Wake Practice	Raleigh	North Carolina
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,