Ovarian CancerPhase 1/2NCT01535157
Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
A Phase 1/2 study testing Fenretinide/LXS + Ketoconazole in people with Ovarian Cancer and Cancer of Ovary, run by South Plains Oncology Consortium at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Cancer of Ovary, Cancer of the Ovary
- What is being tested?
- Fenretinide/LXS + Ketoconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2012to Jun 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79416
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
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.
Read the 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
- Conditions
- Ovarian Cancer, Cancer of Ovary, Cancer of the Ovary, Ovary Neoplasms, Primary Peritoneal Carcinoma
- Being tested
- Fenretinide/LXS + Ketoconazole
- Keywords
- Chemotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenretinide/LXS + KetoconazoleDrug
Also called 4-HPR, N-(4-hydroxyphenyl)retinamide, Nizoral, Feoris
Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fenretinide/LXS + Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Secondary outcomes (1)
Pharmacokinetics -
Area under the plasma concentration versus time curve (AUC) steady state plasma concentrations; drug levels in plasma
Measured: up to 48 months after the last subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: drug combination not providing any efficacy. Will use this data in opening new trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Plains Oncology Consortium
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jayanthi Lea, MD, Study chair, University of Texas Southwestern Medical CenterBarry J Maurer, MD, PhD, Study director, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535157
- Sponsor's protocol ID
- SPOC-2011-001
- Status last verified
- Aug 2020
- First submitted
- 3 Feb 2012
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT01535157
- Acronym / sponsor ID
- SPOC-2011-001
- Conditions
- Ovarian Cancer, Cancer of Ovary, Cancer of the Ovary, Ovary Neoplasms, Primary Peritoneal Carcinoma
- Keywords
- Chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: drug combination not providing any efficacy. Will use this data in opening new trial
- Enrolment
- 12 participants (actual)
- Lead sponsor
- South Plains Oncology ConsortiumResearch network
- Study start
- Feb 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fenretinide/LXS + Ketoconozale | Experimental | Drug: Fenretinide/LXS + KetoconazoleOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenretinide/LXS + KetoconazoleAlso: 4-HPR, N-(4-hydroxyphenyl)retinamide, Nizoral, FeorisStarting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day | Drug | Fenretinide/LXS + Ketoconozale |
Primary outcome
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)
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)
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)
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)
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.
1 secondary outcome
Pharmacokinetics -
Time frame: up to 48 months after the last subject enrolled
Results and safety
The study was stopped early (reason given: drug combination not providing any efficacy. Will use this data in opening new trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Click here for more information about the South Plains Oncology ConsortiumLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayanthi Lea, MD study chair
University of Texas Southwestern Medical Center
Barry J Maurer, MD, PhD study director
Texas Tech University Health Sciences Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fenretinide/LXS + Ketoconazole in people with Ovarian Cancer and Cancer of Ovary, run by South Plains Oncology Consortium at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: drug combination not providing any efficacy. Will use this data in opening new trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.