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NCT00569673 · ClinicalTrials.gov registry record · Phase 2
Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer
A Phase 2 study, sponsored by Gynecologic Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT00569673: Completed Phase 2 study, sponsored by Gynecologic Oncology Group.
NCT00569673 is a Phase 2 study that has completed, run by Gynecologic Oncology Group. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00569673, a Phase 2 study, has completed, sponsored by Gynecologic Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with G-CSF or pegfilgrastim may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
Primary Outcome
Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum o
Interventions
- DRUG docetaxel
- BIOLOGICAL filgrastim
- BIOLOGICAL pegfilgrastim
- DRUG trabectedin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00569673 record still lists
NCT00569673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which docetaxel is the first listed.
NCT00569673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00569673 about?
NCT00569673 is a clinical study titled "Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer". RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune system recover from the ...
What is the current status of trial NCT00569673?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2008-03.
What interventions are being tested in trial NCT00569673?
The interventions under investigation include: docetaxel (DRUG), filgrastim (BIOLOGICAL), pegfilgrastim (BIOLOGICAL), trabectedin (DRUG).
Who is sponsoring clinical trial NCT00569673?
This trial is sponsored by Gynecologic Oncology Group, which has 154 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00569673's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 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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