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drug combination not providing any efficacy. Will use this data in opening new trial
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenretinide/LXS + Ketoconozale | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenretinide/LXS + Ketoconazole | Drug | Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Progression Free Survival | 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. | From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment) |
| Phase 2: Overall Survival | 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. | From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment) |
| Phase 1: To determine the systemic toxicity profile of 4-HPR/LXS oral powder + ketoconazole | Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. | From time of first dose to the last (average 6 months) |
| Phase 2: Event Free Survival | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - | Area under the plasma concentration versus time curve (AUC) steady state plasma concentrations; drug levels in plasma | up to 48 months after the last subject enrolled |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayanthi Lea, MD | University of Texas Southwestern Medical Center | Study Chair |
| Barry J Maurer, MD, PhD | Texas Tech University Health Sciences Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States | ||
| The University of Texas Southwestern Medical Center |
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| Label | URL |
|---|---|
| Click here for more information about the South Plains Oncology Consortium | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D007654 | Ketoconazole |
| D017313 | Fenretinide |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012176 | Retinoids |
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| Dallas |
| Texas |
| 75390 |
| United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79416 | United States |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002338 |
| Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |