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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005849
• Other study ID #: 10337
• Secondary ID: UCCRC-10337NCI-T
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: February 8, 2013
• Start date: April 2000
• Est. completion date: November 2003

Study information

• Verified date: February 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2003
• Est. primary completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• bryostatin 1

• paclitaxel

Locations

Country	Name	City	State
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
United States	Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	Michiana Hematology/Oncology P.C.	South Bend	Indiana
United States	Central Illinois Hematology Oncology Center	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Winegarden JD, Mauer AM, Gajewski TF, Hoffman PC, Krauss S, Rudin CM, Vokes EE. A phase II study of bryostatin-1 and paclitaxel in patients with advanced non-small cell lung cancer. Lung Cancer. 2003 Feb;39(2):191-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate		3 years	No