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Tracking Information | |||||
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First Received Date † | March 29, 2006 | ||||
Last Updated Date | July 23, 2008 | ||||
Start Date † | May 2006 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00309959 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer | ||||
Official Title † | A Phase II Evaluation of ABI-007 (IND #55,974) in the Treatment of Persistent or Recurrent Squamous or Nonsquamous Cell Carcinoma of the Cervix | ||||
Brief Summary | RATIONALE: 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. PURPOSE: This phase II trial is studying how well ABI-007 works in treating patients with persistent or recurrent cervical cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is an open-label, multicenter study. Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Cervical Cancer | ||||
Intervention † | Drug: paclitaxel albumin-stabilized nanoparticle formulation | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Suspended | ||||
Enrollment † | 60 | ||||
Completion Date | |||||
Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Female | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00309959 | ||||
Responsible Party | |||||
Secondary IDs †† | GOG-0127V | ||||
Study Sponsor † | Gynecologic Oncology Group | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | March 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |