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Sponsored by: |
Medical University of South Carolina |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00287963 |
RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: topotecan hydrochloride Drug: vinorelbine ditartrate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer |
Estimated Enrollment: | 36 |
Study Start Date: | February 2004 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of topotecan.
Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed lung cancer
PATIENT CHARACTERISTICS:
No uncontrolled illness including, but not limited to:
PRIOR CONCURRENT THERAPY:
No concurrent hormones or other chemotherapy except for the following:
United States, South Carolina | |
Hollings Cancer Center at Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Study Chair: | Andrew S. Kraft, MD | Medical University of South Carolina |
Study ID Numbers: | CDR0000454919, MUSC-104864/725, GSK-100780 |
Study First Received: | February 6, 2006 |
Last Updated: | November 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00287963 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the lung adenosquamous cell lung cancer bronchoalveolar cell lung cancer combined type small cell lung cancer intermediate type small cell lung cancer |
large cell lung cancer lymphocyte-like type small cell lung cancer recurrent non-small cell lung cancer recurrent small cell lung cancer squamous cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Adenocarcinoma, Bronchiolo-Alveolar Vinblastine Recurrence Carcinoma, Small Cell Adenocarcinoma of lung |
Vinorelbine Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adenocarcinoma Topotecan Carcinoma, Non-Small-Cell Lung |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Enzyme Inhibitors Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |