Clinical trial · Interventional
Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): drug combination not providing any efficacy. Will use this data in opening new trial
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Ovary | Malignant Ovarian Neoplasm | ALIAS | 0.90 |
| Cancer of the Ovary | Malignant Ovarian Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovary Neoplasms | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fenretinide/LXS + Ketoconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fenretinide/LXS + Ketoconozale
- description
- One course is defined as 7 days of Fenretinide/LXS + Ketoconazole followed by 14 days of rest. A course is repeated every 21 days if no evidence of disease progression for six courses.
- interventionNames
- Drug: Fenretinide/LXS + Ketoconazole
Primary outcomes (4)
- measure
- Phase 2: Progression Free Survival
- timeFrame
- From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment)
- description
- 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.
- measure
- Phase 2: Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available