Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-31 @ 4:46 PM
Study NCT ID:
NCT00324012
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2006-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Phase II Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-02
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:
The trial is a phase II trial in adrenocortical carcinoma (ACC), a rare malignancy with poor prognosis. It will provide results leading to the establishment of the effect of the included drugs. The regimen consists of cisplatin plus taxotere. Over a period of 1-2 years this national trial will include 19-36 patients with advanced ACC from different centres in Denmark. Patients not responding to the first line treatment will be switched to the alternative regimen. The primary objective of this trial is to investigate response rate. Secondary endpoints are survival, time to progression, best overall response rate and duration of response.
Detailed Description:
Treatment every three weeks, evaluation after 2 cycles, CTC criterias used for toxicity evaluation
Study Oversight
Has Oversight DMC:
False
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?: