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

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

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

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

Resource links provided by NLM:

Drug Information available for: Cisplatin Docetaxel

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

response rate [ Time Frame: in months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival, time to progression, best overall response rate and duration of response [ Time Frame: survival at 6 months and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	39
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
treatment: Experimental taxotere and cisplatin day one every three weeks	Drug: cisplatin, taxotere cisplatin 75 mg/m2 Taxotere 75 mg/m2

Detailed Description:

Treatment every three weeks, evaluation after 2 cycles, CTC criterias used for toxicity evaluation

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 measurable 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

No publications provided

Responsible Party:	Rigshospitalet ( Gedske Daugaard )
Study ID Numbers:	02 262098
Study First Received:	May 8, 2006
Last Updated:	September 23, 2009
ClinicalTrials.gov Identifier:	NCT00324012 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:

Adrenocortical Carcinoma
cisplatin
taxotere

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Adrenocortical Carcinoma
Physiological Effects of Drugs
Adrenal Gland Diseases
Endocrine System Diseases
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms

Adrenal Gland Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Adrenal Cortex Neoplasms
Adenocarcinoma
Adrenal Cortex Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010