Cancer of Ovary, Cancer of the Ovary, Ovarian Cancer, Ovary Neoplasms, Primary Peritoneal Carcinoma
Conditions
Keywords
Chemotherapy
Brief summary
The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma. In addition, researchers would like to determine if the drugs are most effective together or if fenretinide (4-HPR/LXS) is most effective alone.
Detailed description
In this study, an initial Phase I component of six patients will be conducted to monitor for potential toxicities as this wil be the initial adult experience of fenretinide (4-HPR) given together with ketoconazole
Interventions
DRUGFenretinide/LXS + Ketoconazole
Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day
Sponsors
South Plains Oncology Consortium
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recurrent epithelial ovarian cancer or primary peritoneal carcinoma that can be platinum sensitive or platinum resistant * SWOG Performance Status 0-2 * Previously received a platinum and paclitaxel containing regimen * Projected Life Expectancy of at least 3 months * Adequate bone marrow function * Adequate organ function * Must have received at least 1 prior salvage regimen for recurrent ovarian cancer * Recovery from acute toxicities from surgery, radiation or chemotherapy * At least 3 weeks from last therapy
Exclusion criteria
* Prior fenretinide oral capsule use allowed. If prior IV fenretinide use, must contact study chair for eligibility * Second malignancy within last 5 years * Use of concomitant antioxidants, such as vitamin C or E * Untreated or symptomatic brain metastases * History of hypertriglyceride levels \> 200 mg/dl; triglyceride levels \< 200 and receiving treatment are okay. * Use of certain medications is prohibited - contact study coordinator for information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Progression Free Survival | From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment) | The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier. |
| Phase 2: Overall Survival | From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment) | The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier. |
| Phase 1: To determine the systemic toxicity profile of 4-HPR/LXS oral powder + ketoconazole | From time of first dose to the last (average 6 months) | Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. |
| Phase 2: Event Free Survival | From enrollment up to the first date of progressive disease or death from any cause (up to 48 months after last patient entered on treatment) | The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics - | up to 48 months after the last subject enrolled | Area under the plasma concentration versus time curve (AUC) steady state plasma concentrations; drug levels in plasma |
Countries
United States
Outcome results
None listed