Phase II Study of Bryostatin-1 in Combination With Paclitaxel for Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase II Study of Bryostatin-1 in Combination With Paclitaxel for Non-Small Cell Lung Cancer
OBJECTIVES: I. Determine the overall, partial, and complete response rates in patients with
stage IIIB-IV or recurrent non-small cell lung cancer treated with bryostatin 1 and
paclitaxel. II. Determine the overall survival and time to tumor progression in patients
treated with this regimen. III. Determine the T cell subset analysis and serum levels of
interleukin-6 and tumor necrosis factor alpha in these patients after receiving bryostatin 1
and correlate with clinical endpoints.
OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour on days 1,
8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4
weeks for a minimum of 2 courses in the absence of disease progression or unacceptable
toxicity. Patients are followed for at least 2 years for survival.
PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study within 1 year.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical response rate
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Ann M. Mauer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Chicago
Authority:
United States: Federal Government
Study ID:
10337
NCT ID:
NCT00005849
Start Date:
April 2000
Completion Date:
November 2003
Related Keywords:
- Lung Cancer
- recurrent 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 Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
| Evanston Northwestern Health Care | Evanston, Illinois 60201 |
| Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
| University of Illinois at Chicago | Chicago, Illinois 60612 |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
| Central Illinois Hematology Oncology Center | Springfield, Illinois 62701 |
| Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne, Indiana 46885-5099 |
| Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |
| Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
