NCT00194935

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Feb 2003

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

September 13, 2006

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

September 12, 2006

Conditions

Ovarian Cancer

Keywords

Ovarian CancerCancer of the Ovary

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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.

Interventions

TopotecanDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with a concomitant malignancy other than squamous cell or basal cell skin cancer.
  • Patients who are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medcial College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Thomas Caputo, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

February 1, 2003

Study Completion

August 1, 2006

Last Updated

September 13, 2006

Record last verified: 2006-09

Locations

US(1)