Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
This study is currently recruiting participants.
Verified February 2012 by South Plains Oncology Consortium
Sponsor:
South Plains Oncology Consortium
Information provided by (Responsible Party):
South Plains Oncology Consortium
ClinicalTrials.gov Identifier:
NCT01535157
First received: February 3, 2012
Last updated: February 16, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Cancer of Ovary Cancer of the Ovary Ovary Neoplasms Primary Peritoneal Carcinoma |
Drug: Fenretinide/LXS + Ketoconazole |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma |
Resource links provided by NLM:
Further study details as provided by South Plains Oncology Consortium:
Primary Outcome Measures:
- Phase 2: Progression Free Survival [ Time Frame: From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment) ] [ Designated as safety issue: No ]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 [ Time Frame: From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment) ] [ Designated as safety issue: No ]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 [ Time Frame: From time of first dose to the last (average 6 months) ] [ Designated as safety issue: Yes ]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 [ Time Frame: 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) ] [ Designated as safety issue: No ]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 Outcome Measures:
- Pharmacokinetics [ Time Frame: up to 48 months after the last subject enrolled ] [ Designated as safety issue: No ]Area under the plasma concentration versus time curve (AUC) steady state plasma concentrations
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fenretinide/LXS + Ketoconozale
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.
|
Drug: Fenretinide/LXS + Ketoconazole
Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day
Other Names:
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535157
Contacts
| Contact: Amanda K Knight, RN, CCRP | 806-743-2690 | amanda.knight@ttuhsc.edu |
Locations
| United States, Texas | |
| The University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Ying Dong, PhD 214-648-5107 | |
| Contact: Melana Lindsay, MHSA 214-648-3026 | |
| Sub-Investigator: David Miller, MD | |
| Sub-Investigator: Debra Richardson, MD | |
| Sub-Investigator: Scott Purinton, MD | |
| Sub-Investigator: Siobhan Kehoe, MD | |
| Sub-Investigator: Todd Boren, MD | |
| Sub-Investigator: Christa Nagel, MD | |
| Joe Arrington Cancer Research and Treatment Center | Not yet recruiting |
| Lubbock, Texas, United States, 79416 | |
| Contact: Dawn Howerton, RN 806-725-8000 dhowerton@covhs.org | |
| Principal Investigator: Isaac Tafur, MD | |
| Sub-Investigator: Ibrahim Shalaby, MD | |
| Sub-Investigator: David Close, MD | |
| Principal Investigator: Donald Quick, MD | |
Sponsors and Collaborators
South Plains Oncology Consortium
Investigators
| Study Chair: | Jayanthi Lea, MD | University of Texas Southwestern Medical Center |
| Study Director: | Barry J Maurer, MD, PhD | Texas Tech University Health Sciences Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | South Plains Oncology Consortium |
| ClinicalTrials.gov Identifier: | NCT01535157 History of Changes |
| Other Study ID Numbers: | SPOC-2011-001 |
| Study First Received: | February 3, 2012 |
| Last Updated: | February 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by South Plains Oncology Consortium:
|
Chemotherapy |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Ovarian Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Ketoconazole Fenretinide 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses Antineoplastic Agents Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013