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NCT00653328 · ClinicalTrials.gov registry record · Phase 2
Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00653328: Clinical Trial Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT00653328 is a Phase 2 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00653328, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
RATIONALE: There is emerging data to suggest that the optimal use of angiogenesis inhibitors may be in combination with chemotherapy. The optimal use of atrasentan may be in combination with chemotherapy in women with relapsed and refractory ovarian cancer,fallopian tube cancer, and peritoneal serous papillary adenocarcinoma. Due to its manageable toxicity profile, ease of administration, and activity in both platinum sensitive as well as platinum-resistant patients, Doxil has become the 2nd-line treatment of choice for women with advanced stage ovarian cancer that has progressed following 1st-line platinum/taxane therapy. PURPOSE: To determine if a treatment combination of atrasentan + Doxil is an effective 2nd line treatment in patients with recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer.
Primary Outcome
Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level \>=2x baseline and \>=70 IU/ml, confirmed by a second determination at least 28 days after the first determination
Interventions
- DRUG atrasentan hydrochloride
- DRUG doxil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2003-05 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
Why NCT00653328 stopped before completion
NCT00653328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which atrasentan hydrochloride is the first listed.
NCT00653328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00653328 about?
NCT00653328 is a clinical study titled "Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma". RATIONALE: There is emerging data to suggest that the optimal use of angiogenesis inhibitors may be in combination with chemotherapy. The optimal use of atrasentan may be in combination with chemotherapy in women with relapsed and refractory ovarian cancer,fallopian tube cancer, and peritoneal serou...
What is the current status of trial NCT00653328?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2003-05. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00653328?
The interventions under investigation include: atrasentan hydrochloride (DRUG), doxil (DRUG).
Who is sponsoring clinical trial NCT00653328?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00653328's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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