NCT00324012

Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Adrenocortical Carcinoma

Interventions

Type	Name	Description
DRUG	cisplatin, taxotere	cisplatin 75 mg/m2 Taxotere 75 mg/m2

Timeline

• Start date: 2006-04-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2006-05-10
• Last updated: 2012-02-22

Locations

1 site across 1 country: Denmark