Ovarian Cancer, Ovarian Carcinoma, Recurrent Ovarian Cancer, Recurrent Ovarian Carcinoma
Conditions
Keywords
Low Dose Fractionated Whole Abdominal Radiation Therapy, LDFWART, Docetaxel, Ovarian Cancer, Ovarian Carcinoma, Platinum-Resistant
Brief 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.
Interventions
RADIATIONLow 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).
DRUGDocetaxel
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
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Patients must have platinum-resistant disease relapsing within 6 months or less from the date of their last cycle of initial adjuvant chemotherapy recurrent adenocarcinoma from a primary ovarian, tubal, or peritoneal cancer following first-line chemotherapy for metastatic disease. There is no limit on prior number of chemotherapy regimens. Patients who have received prior systemic docetaxel and platinum-based chemotherapy are eligible * 1.1 Patients must have ≥ 1cm measurable disease on imaging studies independent of patients having an optional surgical salvage procedure. * 2\. Patients must have a life expectancy of at least 6 months. * 3\. Patients must have Karnofsky performance status of ≥ 60 or Gynecology Oncology (GOG) performance status of ≤ 2 (see www.GOG.org website). * 4\. Age 18 - 80 years old * 5\. Patients must have an adequate bone marrow, renal, and hepatic function: * 5.1 WBC: ≥ 3,000 /mcl * 5.2 ANC: ≥ 1,500 /mcl * 5.3 Platelets: ≥ 100,000 /mcl * 5.4 Creatinine: \< 2.0 mg/dcl * 5.5 Bilirubin: \< 1.5x institutional normal value * 5.6 LDH, GGT, SGPT (ALT), SGOT (AST), and ALK Phos:\< 3x institutional normal value. * 6\. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* 1\. Patients who have received prior radiotherapy to the chest, whole abdomen, or lower extremities above the knees. * 2\. Patients who have received prior radiation therapy to the head, neck, or lower extremities below the knees if greater than 3 years prior to study entry. * 3\. Evidence of extra-abdominal extension of disease (such as groin nodes, lung, supraclavicular nodes, and pleural fluid). * 4\. Patients may not be receiving any other investigational agents within 4 weeks preceding the start of study treatment) or chemotherapy for at least 3 weeks preceding the start of study treatment. * 5\. Patients who have been diagnosed with another prior malignant tumor within 3 years of study entry, excluding non-melanoma skin cancer and carcinoma in situ of the cervix. * 6\. Patients with prior history of a severe hypersensitivity reaction to paclitaxel (polysorbate 80-Cremophor). * 7\. Patients with current history of uncontrolled hypertension, angina pectoris, heart failure, cardiac dysrhythmias, pericardial disease, cardiomyopathy, or active infection. * 8\. Presence of any medical condition that in the opinion of the investigator deems the patient unable to participate. * 9\. Females of child-bearing potential. It is expected that ovarian cancer patients would have had a hysterectomy and/or oophorectomy as part of the original standard of care. * 10\. Patients that are \< 18 yrs. of age or \> 80 yrs. of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | 3 years | Number of subjects experiencing adverse events after receiving protocol therapy. |
| Recommended Phase II Dose of LDFWART | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy | 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 | 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. | Up to 5 years | Length of time from start of treatment to the time of documented disease progression in study subjects |
Outcome results
None listed