Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001339
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Study of Combination Chemotherapy and Surgical Resection in the Treatment of Adrenocortical Carcinoma Continuous Infusion Doxorubicin Vincristine and Etoposide With Daily Mitotane Before and After Surgical Resection
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Study of Combination Chemotherapy and Surgical Resection in the Treatment of Adrenocortical Carcinoma Continuous Infusion Doxorubicin Vincristine and Etoposide With Daily Mitotane Before and After Surgical Resection
Status:
COMPLETED
Status Verified Date:
2002-08
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:
Patients who have no response to preoperative chemotherapy and no residual disease following surgery on Regimen A are treated on Regimen B postoperatively
The following acronyms are used
DDD Mitotane NSC-38721
DOX Doxorubicin NSC-123127
VCR Vincristine NSC-67574
VP-16 Etoposide NSC-141540
Regimen A 4-Drug Combination Chemotherapy followed by Surgery followed by 4-Drug Combination Chemotherapy DDDDOXVCRVP-16 followed by surgical debulking followed by DDDDOXVCRVP-16
Regimen B Single-Agent Chemotherapy DDD
The following acronyms are used
DDD Mitotane NSC-38721
DOX Doxorubicin NSC-123127
VCR Vincristine NSC-67574
VP-16 Etoposide NSC-141540
Regimen A 4-Drug Combination Chemotherapy followed by Surgery followed by 4-Drug Combination Chemotherapy DDDDOXVCRVP-16 followed by surgical debulking followed by DDDDOXVCRVP-16
Regimen B Single-Agent Chemotherapy DDD
Detailed Description:
This is a study of infusional doxorubicin vincristine and etoposide in combination with daily oral mitotane in patients with adrenocortical cancer Although mitotane has been used extensively in adrenocortical cancer and has documented single agent activity only limited experience is available in the use of mitotane in combination with chemotherapy In this trial the primary reason for using mitotane is an attempt to enhance therapeutic efficacy based on its documented in-vitro activity as an antagonist of P-glycoprotein The goal of this study is to determine the efficacy of this therapy by treating patients who are considered candidates for surgical resection at presentation or following a response to therapy Following chemotherapy patients deemed surgical candidates can undergo surgical resection with evaluation of response Patients responding to chemotherapy will resume the combination treatment after surgery Patients who do not respond will be maintained on single agent mitotane until it is deemed ineffective
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 |
|---|---|---|---|
| 93-C-0200 | None | None | None |