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| Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005849 |
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 II |
| MedlinePlus related topics: | Cancer Lung Cancer |
| Drug Information available for: | Paclitaxel Bryostatin 1 |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Bryostatin-1 in Combination With Paclitaxel for Non-Small Cell Lung Cancer |
| Study Start Date: | April 2000 |
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 |
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| United States, Illinois | |||||
| Central Illinois Hematology Oncology Center | |||||
| Springfield, Illinois, United States, 62701 | |||||
| Decatur Memorial Hospital Cancer Care Institute | |||||
| Decatur, Illinois, United States, 62526 | |||||
| Evanston Northwestern Health Care | |||||
| Evanston, Illinois, United States, 60201 | |||||
| Louis A. Weiss Memorial Hospital | |||||
| Chicago, Illinois, United States, 60640 | |||||
| Lutheran General Cancer Care Center | |||||
| Park Ridge, Illinois, United States, 60068 | |||||
| Oncology/Hematology Associates of Central Illinois, P.C. | |||||
| Peoria, Illinois, United States, 61602 | |||||
| University of Chicago Cancer Research Center | |||||
| Chicago, Illinois, United States, 60637 | |||||
| University of Illinois at Chicago | |||||
| Chicago, Illinois, United States, 60612 | |||||
| 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 | |||||
| University of Chicago |
| National Cancer Institute (NCI) |
| Study Chair: | Ann M. Mauer, MD | University of Chicago |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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| Study ID Numbers: | CDR0000067867, UCCRC-10337, NCI-T99-0018 |
| First Received: | June 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005849 |
| Health Authority: | United States: Federal Government |
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