Weekly Topotecan Therapy in Patients With Ovarian Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00194935 |
Recruitment Status :
Terminated
First Posted : September 19, 2005
Last Update Posted : September 13, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer | Drug: Topotecan | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 32 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy |
Study Start Date : | February 2003 |
Study Completion Date : | August 2006 |

- The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer.
- To determine the efficacy (Progression free survival) of weekly topotecan as consolidation therapy in ovarian cancer patients who are clinically NED or have microscopic disease only after first-line chemotherapy.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have a histopathologic diagnosis of epithelial ovarian cancer.
- Patients must have completed front-line chemotherapy and be clinically NED (CA 125 <35, negative CT scan, negative physical exam).
- Patients may have a second look laparoscopy, however, there must be no gross disease present (microscopic disease or pathologically negative).
- Patients must not have had other myelosuppressive therapy within four weeks of initiating topotecan therapy.
- Topotecan treatment must begin within 10 weeks following last cycle of initial chemotherapy.
- Patients may have had only one prior chemotherapy regimen.
Exclusion Criteria:
- Patients with a concomitant malignancy other than squamous cell or basal cell skin cancer.
- Patients who are pregnant or breast-feeding.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194935
United States, New York | |
Weill Medcial College of Cornell University | |
New York, New York, United States, 10021 |
Principal Investigator: | Thomas Caputo, M.D. | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00194935 History of Changes |
Other Study ID Numbers: |
0103-636 |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | September 13, 2006 |
Last Verified: | September 2006 |
Ovarian Cancer Cancer of the Ovary |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Topotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |