Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257816
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2005-11-21
Brief Title:
Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
A Pilot Study of Weekly IV Topotecan and Cisplatin With Concurrent Pelvic Radiation in the Treatment of Stages IB2 - IVA Cervical Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-02
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:
There will be approximately 14000 new patients with invasive cervical cancer diagnosed in the United States in 2003 with about 4000 deaths from this disease This accounts for approximately 17 of all deaths due to gynecologic cancers Radiation has been the primary treatment modality for locoregionally advanced cervical cancer Recent trials of concomitant systemic cisplatin chemotherapy and radiation have shown high response rates RR with improvements in durable remissions and overall survival Though the incidence and mortality in the US dropped steadily from years 1940 to 2000 there has recently been a plateau arresting the decline With the routine addition of systemic Cisplatin CDDP chemotherapy to local regional radiation mortality from advanced cervical cancer in the United States is expected to further decrease However further advances in this disease are needed
Detailed Description:
All eligible patients with invasive squamous cell adenocarcinoma or adenosquamous carcinoma of the cervix Stages I-B2 II-B III-B and IV-A will experience clinical staging as permitted by FIGO staging criteria
Primary Objective
Feasibility and toxicity of administering weekly Topotecan among patients with carcinoma of the cervix receiving concurrent pelvic radiation and Cisplatin
Secondary Objectives
To assess the efficacy of administering weekly Topotecan to patients with carcinoma of the cervix receiving concurrent pelvic radiation and Cisplatin on
progression-free survival
overall survival and
local control
Statistic This is a feasibility study A two phase accrual will be utilized If none or 1 of the 6 patients in the first Stage of accrual finish the prescribed therapy in over 8 weeks then the second Stage of accrual an additional 6 patients will increase the Topotecan dose to 3 mgm2 on days 1 8 15 22 29 and once during parametrial boost 6 cycles If 2 or 3 of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks the dose of the Topotecan will remain the same in the second Phase of accrual If 4 or more of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks there will be no second phase of accrual
Primary Objective
Feasibility and toxicity of administering weekly Topotecan among patients with carcinoma of the cervix receiving concurrent pelvic radiation and Cisplatin
Secondary Objectives
To assess the efficacy of administering weekly Topotecan to patients with carcinoma of the cervix receiving concurrent pelvic radiation and Cisplatin on
progression-free survival
overall survival and
local control
Statistic This is a feasibility study A two phase accrual will be utilized If none or 1 of the 6 patients in the first Stage of accrual finish the prescribed therapy in over 8 weeks then the second Stage of accrual an additional 6 patients will increase the Topotecan dose to 3 mgm2 on days 1 8 15 22 29 and once during parametrial boost 6 cycles If 2 or 3 of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks the dose of the Topotecan will remain the same in the second Phase of accrual If 4 or more of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks there will be no second phase of accrual
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 |
|---|---|---|---|
| 2003-3394 | OTHER | University of California Irvine | None |