Overview

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

Status:
Completed
Trial end date:
2001-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Gemcitabine
Tacedinaline
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