ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
Recruitment status was Active, not recruiting
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.
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Genetic: protein expression analysis
Other: enzyme-linked immunosorbent assay
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Antitumor activity [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Correlation between SPARC protein expression and response to ABI-007 therapy [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Estimated Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
- Estimate the antitumor activity of ABI-007 in patients with persistent or recurrent squamous or nonsquamous cell carcinoma of the cervix who have failed on higher-priority treatment protocols.
- Determine the nature and degree of toxicity of ABI-007 in this cohort of patients.
- To determine the expression of the SPARC (secreted protein, acidic and rich in cysteine) protein in the tumor tissue and plasma (exploratory study) of patients treated with this regimen.
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.
Blood samples are collected at baseline and periodically during study for SPARC protein expression analysis by ELISA. Archived tumor tissue samples are also analyzed.
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.