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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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).
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).
Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability
Number of subjects experiencing adverse events after receiving protocol therapy.
Time frame: 3 years
Recommended Phase II Dose of LDFWART
The recommended phase II dose of low-dose whole abdominal radiation therapy (LDFWART) when used in conjunction with 6 cycles of docetaxel chemotherapy.
Time frame: 3 years
Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy
Number of subjects experiencing complete response (CR) or partial response (PR) according to RECIST Criteria Version 1.1
Time frame: Up to 5 years
The rate of Overall Survival in subjects receiving protocol therapy
Observed length of life from start of treatment to cause of death
Time frame: Up to 5 years
The rate of Progression-Free Survival in subjects receiving protocol therapy.
Length of time from start of treatment to the time of documented disease progression in study subjects
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.