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Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

NCT00324012 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2012-02-22

No results posted yet for this study

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.

Conditions

  • Adrenocortical Carcinoma

Interventions

DRUG

cisplatin, taxotere

cisplatin 75 mg/m2 Taxotere 75 mg/m2

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Gedske Daugaard, M.D., DMSc · Rigshospitalet, Denmark

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00324012 on ClinicalTrials.gov