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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00182676 |
RATIONALE: Topotecan may stop the growth of solid tumors by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying how well topotecan works in treating patients with metastatic or unresectable solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: topotecan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Trial of Oral Topotecan for the Treatment of Refractory Advanced Solid Neoplasms Expressing HIF-1α |
Estimated Enrollment: | 20 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
Patients receive oral topotecan once daily on days 1-5 and 8-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients who are in remission are followed every 3 months until the start of salvage therapy.
PROJECTED ACCRUAL: A total of 13-20 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
No known brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Giovanni Melillo, MD | National Cancer Institute - Frederick |
Principal Investigator: | Shivaani Kummar, MD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000439524, NCI-05-C-0186 |
Study First Received: | September 15, 2005 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00182676 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Topotecan |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |