Overview

Bryostatin 1 Plus Paclitaxel in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-small Cell Lung Cancer

Status:
Completed
Trial end date:
2003-11-01
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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 plus paclitaxel in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Chicago
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Bryostatin 1
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage IIIB, IV or recurrent
non-small cell lung cancer (NSCLC) Patients with stage IIIB disease must have pleural
effusion Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100%
Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute
neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic:
Bilirubin normal SGOT less than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL
OR Creatinine clearance at least 50 mL/min Blood urea nitrogen less than 1.5 times normal
Cardiovascular: No symptomatic congestive heart failure, unstable angina pectoris, or
myocardial infarction within the past 6 months No heart block worse than first degree,
bundle branch block, or ventricular or supraventricular arrhythmia by 12 lead
electrocardiogram Other: Not pregnant or nursing Fertile patients must use effective
contraception No uncontrolled concurrent illness including, but not limited to, ongoing or
active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony-stimulating factors
Chemotherapy: No prior chemotherapy for NSCLC Endocrine therapy: Not specified
Radiotherapy: Greater than 4 weeks since prior radiotherapy Surgery: Not specified Other:
No other concurrent investigational agents No concurrent antiretroviral therapy (HAART) in
HIV positive patients