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NCT00309959 · ClinicalTrials.gov registry record · Phase 2
ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase 2 study of Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma, sponsored by Gynecologic Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 20
- Study locations
NCT00309959: Completed Phase 2 study of Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma, sponsored by Gynecologic Oncology Group.
NCT00309959 is a Phase 2 study of Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma that has completed, run by Gynecologic Oncology Group. The registered enrollment target is 37 participants, below the 120-participant average among 13 other Cervical Squamous Cell Carcinoma trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00309959, a Phase 2 study of Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma, has completed, sponsored by Gynecologic Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial is studying how well ABI-007 works in treating patients with persistent or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Primary Outcome
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as 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. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Study Locations (20)
Iowa
- Iowa Methodist Medical Center - Des Moines
- Iowa Oncology Research Association CCOP - Des Moines
- Medical Oncology and Hematology Associates-Des Moines - Des Moines
- Medical Oncology and Hematology Associates-Laurel - Des Moines
- Mercy Medical Center - Des Moines - Des Moines
- Iowa Lutheran Hospital - Des Moines
New Jersey
- Cooper Hospital University Medical Center - Camden
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County - Mount Holly
- Virtua West Jersey Hospital Voorhees - Voorhees Township
Illinois
- Rush University Medical Center - Chicago
- Carle Clinic-Urbana Main - Urbana
Ohio
- Cleveland Clinic Foundation - Cleveland
- Lake University Ireland Cancer Center - Mentor
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
- Tulsa Cancer Institute - Tulsa
Colorado
- University of Colorado Cancer Center - Anschutz Cancer Pavilion - Aurora
Missouri
- Mercy Hospital Springfield - Springfield
Nevada
- Women's Cancer Center of Nevada - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2006-11 |
| Phase | Phase 2 |
What the finished NCT00309959 record still lists
NCT00309959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 120-participant average among 13 other Cervical Squamous Cell Carcinoma trials with a reported enrollment target (69% lower).
The record links to 5 conditions, with Cervical Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00309959 names 20 study sites across 10 states, led by Iowa, New Jersey, Illinois.
Frequently Asked Questions
What is clinical trial NCT00309959 about?
NCT00309959 is a clinical study titled "ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer". This phase II trial is studying how well ABI-007 works in treating patients with persistent or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
What is the current status of trial NCT00309959?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2006-11.
What conditions does trial NCT00309959 study?
This clinical trial studies the following conditions: Cervical Squamous Cell Carcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Recurrent Cervical Carcinoma, Cervical Small Cell Carcinoma.
What interventions are being tested in trial NCT00309959?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Paclitaxel Albumin-Stabilized Nanoparticle Formulation (DRUG).
Who is sponsoring clinical trial NCT00309959?
This trial is sponsored by Gynecologic Oncology Group, which has 154 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00309959 being conducted?
This trial has 20 study locations across Colorado, Illinois, Iowa, Missouri, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00309959's enrollment target sits among peer trials
37 10th of 13 higher than 4 of 13 other Cervical Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Squamous Cell 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.
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