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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00309959 |
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.
Condition | Intervention | Phase |
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Cervical Cancer |
Drug: paclitaxel albumin-stabilized nanoparticle formulation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease, defined as at least one target lesion that can be accurately measured in at least one dimension ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT scan , or MRI, or ≥ 10 mm when measured by spiral CT scan
Must have received 1 prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent squamous or nonsquamous cell carcinoma of the cervix
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Hormonal therapy directed at malignant tumor must be discontinued at least 1 week prior to study entry
No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
No prior radiotherapy to any portion of the abdominal cavity or pelvis
No prior chemotherapy for any abdominal or pelvic tumor
Study Chair: | David S. Alberts, MD | University of Arizona |
Study ID Numbers: | CDR0000463520, GOG-0127V |
Study First Received: | March 29, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00309959 |
Health Authority: | United States: Food and Drug Administration |
recurrent cervical cancer cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical small cell carcinoma cervical squamous cell carcinoma |
Epidermoid carcinoma Carcinoma, Small Cell Paclitaxel Squamous cell carcinoma Carcinoma, squamous cell |
Adenocarcinoma Carcinoma, Squamous Cell Carcinoma, Adenosquamous Recurrence Carcinoma |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |