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Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: April 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsored by: Pfizer Incorporated - Ann Arbor
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005093
  Purpose

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 Intervention Phase
Lung Cancer
Drug: acetyldinaline
Drug: gemcitabine hydrochloride
Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Gemcitabine Gemcitabine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1999
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005093

Locations
United States, California
Cedars-Sinai Comprehensive Cancer Center
Los Angeles, California, United States, 90048
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Massachusetts
New England Medical Center Hospital
Boston, Massachusetts, United States, 02111
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
United States, North Carolina
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, United States, 27609
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
United States, Tennessee
West Clinic, P.C.
Memphis, Tennessee, United States, 38117
United States, Texas
Southwest Regional Cancer Center
Austin, Texas, United States, 78705
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 1J8
Canada, Ontario
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Pfizer Incorporated - Ann Arbor
Investigators
Study Chair: Kathryn Kimmel, PhD Pfizer Incorporated - Ann Arbor
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067735, PD-994-013, ILEX-994-013
Study First Received: April 6, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005093     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Antimetabolites
Immunologic Factors
Antiviral Agents
Immunosuppressive Agents
Recurrence
Carcinoma
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009