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NCT00477386 · ClinicalTrials.gov registry record · Phase 1
Trial of Decitabine as a Sensitizer to Carboplatin in Platinum Resistant Recurrent Ovarian Cancer
A Phase 1 study of Ovarian Cancer, sponsored by Indiana University.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT00477386: Completed Phase 1 study of Ovarian Cancer, sponsored by Indiana University.
NCT00477386 is a Phase 1 study of Ovarian Cancer that has completed, run by Indiana University. The registered enrollment target is 28 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00477386, a Phase 1 study of Ovarian Cancer, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Based on these pre-clinical data, which were generated by our group, the investigators propose to test in a phase I/II clinical trial the following hypothesis: demethylation induced by decitabine results in re-sensitization to platinum in recurrent ovarian cancer. To test this hypothesis, the investigators will treat patients with recurrent ovarian cancer platinum resistant (recurrence within 6 months from platinum therapy) or platinum-refractory (no response to platinum) with a combination consisting of decitabine and carboplatin. This will be an institutional open label phase I/II trial to determine the safety and the biologic activity of the Decitabine/Carboplatin combination. The investigators will determine whether Carboplatin can be safely combined with Decitabine, the optimal dose schedule and the investigators will define whether at this dosage, the regimen is biologically active (i.e. induces demethylation of target genes). In the second part of the trial, the investigators will determine the clinical activity of the combination in a population of patients with platinum-resistant ovarian cancer.
Primary Outcome
The definition of MTD will follow the standard definition of the phase I 3+3 trial concept. Dose Limiting Toxicities (DLTs) will be scored in the first cycle. Patients will be monitored for 28 days (a cycle) to determine whether a DLT is experienced for the specific dose level.
Conditions Studied
Interventions
- DRUG decitabine
Study Locations (1)
Indiana
- Indiana University Cancer Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-07 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT00477386 record still lists
NCT00477386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which decitabine is the first listed.
NCT00477386 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT00477386 about?
NCT00477386 is a clinical study titled "Trial of Decitabine as a Sensitizer to Carboplatin in Platinum Resistant Recurrent Ovarian Cancer". Based on these pre-clinical data, which were generated by our group, the investigators propose to test in a phase I/II clinical trial the following hypothesis: demethylation induced by decitabine results in re-sensitization to platinum in recurrent ovarian cancer. To test this hypothesis, the inves...
What is the current status of trial NCT00477386?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2007-07. Estimated completion is 2013-09.
What conditions does trial NCT00477386 study?
This clinical trial studies the following conditions: Ovarian Cancer.
What interventions are being tested in trial NCT00477386?
The interventions under investigation include: decitabine (DRUG).
Who is sponsoring clinical trial NCT00477386?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00477386 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00477386's enrollment target sits among peer trials
28 264th of 322 higher than 59 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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