Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-25 @ 1:25 PM
Study NCT ID:
NCT00309959
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2006-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
Study Overview
Official Title:
A Phase II Evaluation of ABI-007 in the Treatment of Persistent or Recurrent Squamous or Nonsquamous Cell Carcinoma of the Cervix
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
OBJECTIVES:
I. 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.
II. Determine the nature and degree of toxicity of ABI-007 in this cohort of patients.
III. 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.
I. 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.
II. Determine the nature and degree of toxicity of ABI-007 in this cohort of patients.
III. 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: