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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00005093

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: gemcitabine hydrochloride Drug: tacedinaline	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 1999

Actual Study Completion Date :

May 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Comprehensive Cancer Center	Los Angeles	California	United States	90048
2	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
3	New England Medical Center Hospital	Boston	Massachusetts	United States	02111
4	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0752
5	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201
6	Raleigh Hematology/Oncology Associates - Wake Practice	Raleigh	North Carolina	United States	27609
7	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210
8	West Clinic, P.C.	Memphis	Tennessee	United States	38117
9	Southwest Regional Cancer Center	Austin	Texas	United States	78705
10	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
11	British Columbia Cancer Agency - Fraser Valley Cancer Centre	Surrey	British Columbia	Canada	V3V 1Z2
12	BC Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
13	British Columbia Cancer Agency - Vancouver Island Cancer Centre	Victoria	British Columbia	Canada	V8R 1J8
14	Ottawa Regional Cancer Center - General Division	Ottawa	Ontario	Canada	K1H 8L6
15	Mount Sinai Hospital - Toronto	Toronto	Ontario	Canada	M5G 1X5
16	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9