LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma
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|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Recruitment Status : Withdrawn (Study voluntarily stopped by Principal Investigator due to lack of accrual.)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|
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: LDFWART
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083536
|Principal Investigator:||Aaron H Wolfson, MD||University of Miami|