NCT00170677

Brief Summary

Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for phase_2 ovarian-cancer

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 14, 2014

Status Verified

July 1, 2010

Enrollment Period

7.3 years

First QC Date

September 13, 2005

Last Update Submit

May 13, 2014

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of CR and PR in each arm

    every 12 weeks

Secondary Outcomes (2)

  • Toxicity of topotecan treatment

    after each cycle

  • Progression-free survival of both arms

    every 12 weeks

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Topotecan

B

EXPERIMENTAL
Drug: Topotecan

Interventions

TopotecanDRUG

Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.

B

Eligibility Criteria

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

You may qualify if:

  • patients with histologically-confirmed ovarian cancer
  • relapse within 6 month after primary therapy
  • primary therapy with platin and taxan
  • ECOG 0-2
  • \>= 18 years
  • leukocytes \>= 3.000/ µl
  • platelet \>= 100.000/ µl
  • neutrophil \>= 1.500/ µl
  • written informed consent

You may not qualify if:

  • earlier topotecan therapy
  • simultaneous or planned radiotherapy
  • secondary malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Campus Virchow-Klinikum

Berlin, 13533, Germany

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

  • Werner Lichtenegger

    Charite University, Berlin, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 14, 2014

Record last verified: 2010-07

Locations

DE(1)