Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138151
Status:
TERMINATED
Last Update Posted:
2013-11-20
First Post:
2005-08-29
Brief Title:
Isotretinoin Interferon Alpha-2b and Paclitaxel in Stage IV Recurrent or Persistent Cervical Cancer
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
A Phase II Trial of Chemosensitization With Paclitaxel 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual and lack of study drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Sometimes when chemotherapy is given it does not stop the growth of tumor cells The tumor is said to be resistant to chemotherapy Giving isotretinoin and interferon alpha-2b together with paclitaxel may reduce drug resistance and allow the tumor cells to be killed
PURPOSE This phase II trial is studying how well giving isotretinoin and interferon alpha-2b together with paclitaxel works in treating patients with stage IV recurrent or persistent cervical cancer
PURPOSE This phase II trial is studying how well giving isotretinoin and interferon alpha-2b together with paclitaxel works in treating patients with stage IV recurrent or persistent cervical cancer
Detailed Description:
OBJECTIVES
Determine the response in patients with stage IVB recurrent or persistent cervical cancer treated with isotretinoin interferon alpha-2b and paclitaxel
OUTLINE This is a multicenter study
Patients receive oral isotretinoin and interferon alpha-2b subcutaneously once daily on days 1-4 and paclitaxel IV over 3 hours on day 4 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 27-66 patients will be accrued for this study
Determine the response in patients with stage IVB recurrent or persistent cervical cancer treated with isotretinoin interferon alpha-2b and paclitaxel
OUTLINE This is a multicenter study
Patients receive oral isotretinoin and interferon alpha-2b subcutaneously once daily on days 1-4 and paclitaxel IV over 3 hours on day 4 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 27-66 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA072720 | NIH | None | None |
| CINJ-100101 | OTHER | None | None |
| CINJ-3390 | OTHER | None | None |
| CINJ-NJ1703 | OTHER | Cancer Institute of New Jersey | httpsreporternihgovquickSearchP30CA072720 |