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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00005849
First received: June 2, 2000
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: bryostatin 1
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Bryostatin-1 in Combination With Paclitaxel for Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Clinical response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2000
Study Completion Date: November 2003
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Paclitaxel (90 mg/m2, days 1, 8 and 15 of every 28 day cycle), Bryostatin-1 (50 mcg/m2, days 2, 9 and 16 of every 28 day cycle)
Drug: bryostatin 1 Drug: paclitaxel

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005849

Locations
United States, Illinois
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States, 46885-5099
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States, 46617
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Ann M. Mauer, MD University of Chicago
  More Information

Additional Information:
Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00005849     History of Changes
Other Study ID Numbers: 10337, UCCRC-10337, NCI-T99-0018
Study First Received: June 2, 2000
Last Updated: February 8, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Chicago:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bryostatin 1
Paclitaxel
Adjuvants, Immunologic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014