Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054444
Status:
COMPLETED
Last Update Posted:
2014-12-31
First Post:
2003-02-05
Brief Title:
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS
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 I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer This trial is also studying the best dose of topotecan when given in this regimen Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy such as topotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety and tolerability of pelvic radiotherapy cisplatin and topotecan in patients with locally advanced cervical cancer
II Determine the maximum tolerated dose MTD of topotecan when administered in this regimen in this patient population
SECONDARY OBJECTIVES
I Determine the site of recurrence local vs distant in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of topotecan
Patients undergo radiotherapy 5 days a week for 6 weeks Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity Once the MTD is determined an additional cohort of 20 patients receives treatment as above at the MTD
After completion of study treatment patients are followed periodically for 5 years
I Determine the safety and tolerability of pelvic radiotherapy cisplatin and topotecan in patients with locally advanced cervical cancer
II Determine the maximum tolerated dose MTD of topotecan when administered in this regimen in this patient population
SECONDARY OBJECTIVES
I Determine the site of recurrence local vs distant in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of topotecan
Patients undergo radiotherapy 5 days a week for 6 weeks Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity Once the MTD is determined an additional cohort of 20 patients receives treatment as above at the MTD
After completion of study treatment patients are followed periodically for 5 years
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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2009-00617 | REGISTRY | None | None |
| CDR0000270680 | None | None | None |
| GOG-9913 | None | None | None |
| GOG-9913 | OTHER | None | None |
| GOG-9913 | OTHER | None | None |