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LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma

NCT02083536 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-08-10

No results posted yet for this study

Summary

The ultimate clinical aim of this proposed phase I trial is to evaluate the toxicity and determine the recommended phase II dose of combining the effect of LDFWART following administration of docetaxel for 6 cycles in patients with recurrent platinum-resistant ovarian cancer.

Conditions

  • Ovarian Cancer
  • Ovarian Carcinoma
  • Recurrent Ovarian Cancer
  • Recurrent Ovarian Carcinoma

Interventions

RADIATION

Low Dose Fractionated Whole Abdominal Radiation Therapy

A single fraction of LDFWART will be given 6-8 hours after the start of morning administration of Docetaxel for 6 cycles (the time of the start Docetaxel will be counted as the frame of reference for when the LDFWART can be given).

DRUG

Docetaxel

Chemotherapy will consist of 6 cycles of Docetaxel. Each cycle will follow standard of care and will be scheduled every 3 weeks ± 3 days. Chemotherapy should be administered in the morning to allow 6-8 hours before Radiation Therapy. On Day 1 of each cycle, chemotherapy will consist of Docetaxel 60 mg/m² infused intravenously over 30-60 minutes (with premedication of dexamethasone 10 mg given IV 30-60 minutes prior to docetaxel administration).

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Aaron H Wolfson, MD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-05-31

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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 NCT02083536 on ClinicalTrials.gov