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NCT01652794 · ClinicalTrials.gov registry record · Phase 1
Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer
A Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Ovarian Epithelial Cancer, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01652794: Completed Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Ovarian Epithelial Cancer, sponsored by Case Comprehensive Cancer Center.
NCT01652794 is a Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Ovarian Epithelial Cancer that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 12 participants, below the 252-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01652794, a Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Ovarian Epithelial Cancer, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (MTD). To determine the MTD, patients will receive different amounts of carboplatin and gemcitabine.
Primary Outcome
A modified Fibonacci design used during the dose-finding portion of this study. When =\< 1 out of 6 patients enter at highest next dose level below the maximum tolerated dose (MTD), this is the recommended phase 2 dose. At least 6 patients must be entered at the recommended phase 2 dose.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG carboplatin
- RADIATION stereotactic body radiation therapy
- OTHER pharmacogenomic studies
- DRUG gemcitabine hydrochloride
Study Locations (1)
Ohio
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
What the finished NCT01652794 record still lists
NCT01652794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 252-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (95% lower).
The record links to 10 conditions, with Recurrent Endometrial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01652794 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01652794 about?
NCT01652794 is a clinical study titled "Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer". The purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (...
What is the current status of trial NCT01652794?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-05. Estimated completion is 2015-03.
What conditions does trial NCT01652794 study?
This clinical trial studies the following conditions: Recurrent Endometrial Carcinoma, Recurrent Ovarian Epithelial Cancer, Recurrent Fallopian Tube Cancer, Ovarian Sarcoma, Recurrent Cervical Cancer.
What interventions are being tested in trial NCT01652794?
The interventions under investigation include: laboratory biomarker analysis (OTHER), carboplatin (DRUG), stereotactic body radiation therapy (RADIATION), pharmacogenomic studies (OTHER), gemcitabine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01652794?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01652794 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Endometrial Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01652794's enrollment target sits among peer trials
12 20th of 19 the lowest of 19 other Recurrent Endometrial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Endometrial Carcinoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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