Weekly Topotecan Therapy in Patients With Ovarian Cancer - Full Text View

Sponsored by:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00194935

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 II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy

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
Genders 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

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

Study ID Numbers:	0103-636
Study First Received:	September 13, 2005
Last Updated:	September 12, 2006
ClinicalTrials.gov Identifier:	NCT00194935
Health Authority:	United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:

Ovarian Cancer
Cancer of the Ovary

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases

Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Topotecan
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009