Clinical Trial: Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

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 Summary: Treatment every three weeks, evaluation after 2 cycles, CTC criterias used for toxicity evaluation
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome: response rate [ Time Frame: in months ]

Original Primary Outcome: response rate

Current Secondary Outcome: Survival, time to progression, best overall response rate and duration of response [ Time Frame: survival at 6 months and 1 year ]

Original Secondary Outcome: Survival, time to progression, best overall response rate and duration of response

Information By: Rigshospitalet, Denmark

Dates:
Date Received: May 8, 2006
Date Started: April 2006
Date Completion:
Last Updated: February 20, 2012
Last Verified: February 2012