LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma
|ClinicalTrials.gov Identifier: NCT02083536|
Recruitment Status : Withdrawn (Study voluntarily stopped by Principal Investigator due to lack of accrual.)
First Posted : March 11, 2014
Last Update Posted : August 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Ovarian Carcinoma Recurrent Ovarian Cancer Recurrent Ovarian Carcinoma||Radiation: Low Dose Fractionated Whole Abdominal Radiation Therapy Drug: Docetaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Using Low-Dose Fractionated Whole Abdominal Radiation Therapy (LDFWART) As A Docetaxel Chemo-Potentiator for Patients With Platinum-Resistant Recurrent Ovarian Carcinoma|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2019|
U.S. FDA Resources
Experimental: LDFWART + Docetaxel
This study has 6 treatment cycles given at 3 weeks intervals ± 3 days. A cycle is defined as 1 treatment of morning Docetaxel and afternoon Low Dose Fractionated Whole Abdominal Radiation Therapy (LDFWART). The first day of the first treatment is designated "study day 1".
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).
Other Name: LDFWARTDrug: 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).
Other Name: Taxotere
- Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 years ]Number of subjects experiencing adverse events after receiving protocol therapy.
- Recommended Phase II Dose of LDFWART [ Time Frame: 3 years ]The recommended phase II dose of low-dose whole abdominal radiation therapy (LDFWART) when used in conjunction with 6 cycles of docetaxel chemotherapy.
- Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy [ Time Frame: Up to 5 years ]Number of subjects experiencing complete response (CR) or partial response (PR) according to RECIST Criteria Version 1.1
- The rate of Overall Survival in subjects receiving protocol therapy [ Time Frame: Up to 5 years ]Observed length of life from start of treatment to cause of death
- The rate of Progression-Free Survival in subjects receiving protocol therapy. [ Time Frame: Up to 5 years ]Length of time from start of treatment to the time of documented disease progression in study subjects
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083536
|Principal Investigator:||Aaron H Wolfson, MD||University of Miami|