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Phase II Study of Bryostatin-1 in Combination With Paclitaxel for Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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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:


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:


Principal Investigator

Ann M. Mauer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




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



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