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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Kathryn Kimmel, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Pfizer Incorporated - Ann Arbor

Authority:

United States: Federal Government

Study ID:

PD-994-013

NCT ID:

NCT00005093

Start Date:

December 1999

Completion Date:

May 2001

Related Keywords:

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

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
New England Medical Center HospitalBoston, Massachusetts  02111
Southwest Regional Cancer CenterAustin, Texas  78705
West Clinic, P.C.Memphis, Tennessee  38117
Cedars-Sinai Comprehensive Cancer CenterLos Angeles, California  90048
Raleigh Hematology/Oncology Associates - Wake PracticeRaleigh, North Carolina  27609