Weekly Topotecan Therapy in Patients With Ovarian Cancer

This study has been terminated.

Sponsor:

Information provided by:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT00194935

First received: September 13, 2005

Last updated: September 12, 2006

Last verified: September 2006

History of Changes

Purpose

The purpose of this study is to find out the safety and feasibility of weekly topotecan consolidation therapy in patients with ovarian cancer.

Condition	Intervention	Phase
Ovarian Cancer	Drug: Topotecan	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy

Resource links provided by NLM:

Genetics Home Reference related topics: ovarian cancer

MedlinePlus related topics: Ovarian Cancer

Drug Information available for: Topotecan hydrochloride Topotecan

Genetic and Rare Diseases Information Center resources: Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer.

Secondary Outcome Measures:

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.


Estimated Enrollment:	32
Study Start Date:	February 2003
Estimated Study Completion Date:	August 2006

Detailed Description:

Patients with Stage IIIC and IV optimally-debulked ovarian cancer will be treated with 6 cycles (every 3 weeks) of carboplatin (AUC 5) and paclitaxel (175 mg/m2). Patients who demonstrate a complete clinical response to this regimen will then be treated with topotecan consolidation (4 mg/m2 weekly x 8 weeks for one cycle followed by a break in the 9th week) for a maximum of 3 cycles. Primary endpoints will be toxicity and the determination of the appropriate dose, schedule, and duration of topotecan for further consolidation trials.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194935

Locations


United States, New York
Weill Medcial College of Cornell University
New York, New York, United States, 10021

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators


Principal Investigator:	Thomas Caputo, M.D.	Weill Medical College of Cornell University

More Information


ClinicalTrials.gov Identifier:	NCT00194935 History of Changes
Other Study ID Numbers:	0103-636
Study First Received:	September 13, 2005
Last Updated:	September 12, 2006

Keywords provided by Weill Medical College of Cornell University:


Ovarian Cancer Cancer of the Ovary

Additional relevant MeSH terms:


Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms	Endocrine System Diseases Gonadal Disorders Topotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017

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