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Sorafenib + Topotecan for Platinum-Resistant Recurrent Ovarian Cancer

NCT00526799 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-03-03

Study results available
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Summary

This multi-institutional phase I/II clinical trial will test the tolerability and efficacy of the combination sorafenib and topotecan in patients with recurrent ovarian cancer, which is platinum-resistant (recurrence within 6 months from completing platinum based therapy) or refractory (progressive disease during platinum based therapy).

Conditions

Interventions

DRUG

Sorafenib

Phase I: Dose Escalation, Phase II: MTD Dose level -1: 200mg po daily Dose level 1: 400mg po daily (MTD) Dose level 2: 400mg po bid

DRUG

Topotecan

3.5mg/m2 weekly, 3 weeks on and one week off.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Daniela Matei, MD

    lead OTHER

Principal Investigators

  • Daniela Matei, M.D. · Hoosier Oncology Group, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-01-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00526799 on ClinicalTrials.gov