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NCT01196429 · ClinicalTrials.gov registry record · Phase 2
Temsirolimus, Carboplatin, and Paclitaxel as First-Line Therapy in Treating Patients With Newly Diagnosed Stage III-IV Clear Cell Ovarian Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT01196429: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01196429 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01196429, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
This phase II trial studies how well temsirolimus, carboplatin, and paclitaxel as first-line therapy works in treating patients with newly diagnosed stage III-IV clear cell ovarian cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus with combination chemotherapy may be an effective treatment for ovarian cancer.
Primary Outcome
Progression of target lesions (TL) was a \>=20% increase in the sum of the diameters of TL, taking as reference the smallest sum on study (including the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must demonstrate an absolute increase \>=5 mm. Progression of non-target lesions (NTL) as defined as appearance of \>=1 new lesions or unequivocal progression of existing NTL. Unequivocal progression should not normally trump target lesion status
Interventions
- DRUG Carboplatin
- DRUG Docetaxel
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- DRUG Temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2010-08 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
What the finished NCT01196429 record still lists
NCT01196429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01196429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01196429 about?
NCT01196429 is a clinical study titled "Temsirolimus, Carboplatin, and Paclitaxel as First-Line Therapy in Treating Patients With Newly Diagnosed Stage III-IV Clear Cell Ovarian Cancer". This phase II trial studies how well temsirolimus, carboplatin, and paclitaxel as first-line therapy works in treating patients with newly diagnosed stage III-IV clear cell ovarian cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs u...
What is the current status of trial NCT01196429?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2010-08. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01196429?
The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Temsirolimus (DRUG).
Who is sponsoring clinical trial NCT01196429?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01196429's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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