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Sponsors and Collaborators: |
Accelerated Community Oncology Research Network GlaxoSmithKline |
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Information provided by: | Accelerated Community Oncology Research Network |
ClinicalTrials.gov Identifier: | NCT00382733 |
The purpose of this study is to evaluate the effectiveness of oral topotecan and how well the chemotherapy is tolerated (any side effects) when it is given in different dose levels. The study will also collect information on how the medication is being broken down and absorbed in the body and how quality of life is affected during treatment.
Condition | Intervention | Phase |
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Tumors |
Drug: Oral Topotecan |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Oral Topotecan, Utilization for a Metronomic Dosing Schedule to Treat Recurrent or Persistent Solid Tumors |
Estimated Enrollment: | 28 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Women of childbearing potential not using a reliable and appropriate contraceptive method will be excluded. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Patients must agree to continue contraception for 30 days from the date of the last study drug administration.
Contact: Mandy Johns, RHIA, CCRP | 901-435-5578 ext 1527 | ajohns@sosacorn.com |
Contact: Cindy Lee, RN, MSN,CCRP | 901-259-8282 | clee@sosacorn.com |
United States, Tennessee | |
The West Clinic | Recruiting |
Memphis, Tennessee, United States, 38120 | |
Principal Investigator: Todd Tillmanns, M.D. |
Principal Investigator: | Todd D. Tillmanns, M.D. | West Clinic |
Responsible Party: | Accelerated Community Oncology Research Network ( Amanda Johns, RHIA, CCRP ) |
Study ID Numbers: | ACORN ATDTROC0501 |
Study First Received: | September 27, 2006 |
Last Updated: | April 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00382733 History of Changes |
Health Authority: | United States: Institutional Review Board |
Solid Tumors |
Topotecan Recurrence |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Topotecan Pharmacologic Actions |