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NCT00825201 · ClinicalTrials.gov registry record · Phase 1
Intraperitoneal Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Cancer of the Peritoneal Cavity
A Phase 1 study of Ovarian Cancer and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 2
- Study locations
NCT00825201: Completed Phase 1 study of Ovarian Cancer and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by City of Hope Medical Center.
NCT00825201 is a Phase 1 study of Ovarian Cancer and Unspecified Adult Solid Tumor, Protocol Specific that has completed, run by City of Hope Medical Center. The registered enrollment target is 27 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00825201, a Phase 1 study of Ovarian Cancer and Unspecified Adult Solid Tumor, Protocol Specific, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 2
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation directly into the abdomen may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal paclitaxel albumin-stabilized nanoparticle formulation in treating patients with advanced cancer of the peritoneal cavity.
Primary Outcome
The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by CTCAE and nadir or maximum values for the laboratory measures), time of onset (i.e., course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and course.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- DRUG paclitaxel albumin-stabilized nanoparticle formulation
- OTHER mass spectrometry
- OTHER liquid chromatography
Study Locations (2)
California
- City of Hope Medical Center - Duarte
Washington
- Swedish Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2009-01 |
| Est. Completion | 2018-01-16 |
| Phase | Phase 1 |
What the finished NCT00825201 record still lists
NCT00825201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 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 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00825201 reports a single indexed study location in California, Washington.
Frequently Asked Questions
What is clinical trial NCT00825201 about?
NCT00825201 is a clinical study titled "Intraperitoneal Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Cancer of the Peritoneal Cavity". RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation directly into ...
What is the current status of trial NCT00825201?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2009-01. Estimated completion is 2018-01-16.
What conditions does trial NCT00825201 study?
This clinical trial studies the following conditions: Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific, Peritoneal Cavity Cancer.
What interventions are being tested in trial NCT00825201?
The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), paclitaxel albumin-stabilized nanoparticle formulation (DRUG), mass spectrometry (OTHER), liquid chromatography (OTHER).
Who is sponsoring clinical trial NCT00825201?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00825201 being conducted?
This trial has 2 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00825201's enrollment target sits among peer trials
27 265th of 322 higher than 56 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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