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Safety Study Involving Oxaliplatin With Docetaxel for Recurrent Ovarian,Primary Peritoneal, and Fallopian Tube Cancer

NCT00692900 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-03-12

No results posted yet for this study

Summary

The purpose of this study is to determine the safest and maximum tolerated dosing regimens for intraperitoneal oxaliplatin with intravenous docetaxel and intravenous oxaliplatin with intraperitoneal docetaxel for recurrent ovarian, primary peritoneal, or fallopian tube cancer.

Conditions

Interventions

DRUG

intravenous docetaxel with intraperitoneal oxaliplatin

IV docetaxel 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal oxaliplatin escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs.

DRUG

intravenous oxaliplatin with intraperitoneal docetaxel

IV oxaliplatin 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal docetaxel escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Robert P Edwards, MD · University of Pittsburgh Medical Center

  • Kristin Zorn, MD · University of Pittsburgh Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2013-06-30
Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

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 NCT00692900 on ClinicalTrials.gov