Trial With Taxotere and Cisplatin in Non-Operable Adrenocortical Carcinoma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Adrenocortical Carcinoma	Drug: cisplatin, taxotere	Phase II

ChemIDplus related topics:

Docetaxel Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

response rate [ Time Frame: not relevant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival, time to progression, best overall response rate and duration of response [ Time Frame: not relevant ] [ Designated as safety issue: No ]

Estimated Enrollment:	39
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

cisplatin 75 mg/m2 Taxotere 75 mg/m2

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of adrenocortical carcinoma
Locally advanced or metastatic disease not amenable to radical surgery resection (Stage III-IV)
Radiologically monitorable disease
ECOG performance status 0-2
Life expectancy > 3 months
Age ≥18 years
Adequate bone marrow reserve (neutrophils > 1500/mm3 and platelets > 100,000/mm3)
Effective contraception in pre-menopausal female and male patients
Patient's written informed consent
Ability to comply with the protocol procedures (including availability for follow-up visits)
Previous palliative surgery, radiotherapy or radiofrequency ablation is acceptable as long as radiologically monitorable disease is verifiable afterwards.

Exclusion Criteria:

History of prior malignancy, except for cured non-melanoma skin cancer, curatively in situ cervical carcinoma, or other cancers treated with no evidence of disease for at least five years.
Previous cytotoxic chemotherapy for adrenocortical carcinoma
Renal insufficiency (serum creatinine ≥2 mg/dl or creatinine clearance ≤ 60 ml/min)
Hepatic insufficiency (serum bilirubin ≥2 x the institutional upper limit of normal range and/or serum transaminases ≥ 3 x the institutional upper limit of normal range; exception: in patients on mitotane, transaminase levels up to 5 x the institutional upper limit of normal range are acceptable)
Pregnancy or breast feeding
Known hypersensitivity to any drug included in the treatment protocol
Presence of active infection
Any other severe clinical condition that in the judgment of the local investigator would place the patient at undue risk or interfere with the study completion
Current treatment with other experimental drugs and/or previous participation in clinical trials with other experimental agents for adrenocortical carcinoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324012

Contacts


Contact: Gedske Daugaard, M.D., DMSc	45-35-454-677	gedske.daugaard@rh.regionh.dk

Locations


Denmark
	Department of Oncology 5073, Rigshospitalet	Recruiting
	Copenhagen, Denmark, 2100
	Principal Investigator: Gedske Daugaard, M.D., DMSc

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators


Principal Investigator:	Gedske Daugaard, M.D., DMSc	Rigshospitalet, Denmark

Principal Investigator:	Gedske Daugaard, M.D., DMSc	Rigshospitalet, Denmark

More Information

Responsible Party:	Rigshospitalet ( Gedske Daugaard )
Study ID Numbers:	02 262098
First Received:	May 8, 2006
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00324012
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:

Adrenocortical Carcinoma

cisplatin

taxotere

Study placed in the following topic categories:

Adrenocortical Carcinoma

Adrenocortical carcinoma

Adrenal Gland Diseases

Endocrine System Diseases

Carcinoma

Docetaxel

Adrenal Gland Neoplasms

Cisplatin

Adrenal Cortex Neoplasms

Endocrinopathy

Adenocarcinoma

Adrenal Cortex Diseases

Neoplasms, Glandular and Epithelial

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Radiation-Sensitizing Agents

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00324012