Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

Descriptive Information
Brief Title ^†	Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma
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 Description	Treatment every three weeks, evaluation after 2 cycles, CTC criterias used for toxicity evaluation
Study Phase	Phase 2
Study Type ^†	Interventional
Study Design ^†	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure ^†	response rate
Secondary Outcome Measure ^†	Survival, time to progression, best overall response rate and duration of response
Condition ^†	Adrenocortical Carcinoma
Intervention ^†	Drugcisplatin, taxotere
Study Arms / Comparison Groups	treatment taxotere and cisplatin day one every three weeks
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Drug
Estimated Enrollment ^†	19
Start Date ^†	April 2006
Completion Date	February 2012
Primary Completion Date	February 2012
Eligibility 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
Gender	Both
Ages	18 Years - N/A
Accepts Healthy Volunteers	No
Contacts ^††	, , , ,
Location Countries ^†	Denmark,
Administrative Information
NCT ID ^†	NCT00324012
Organization ID	02 262098
Secondary IDs ^††
Responsible Party	,
Study Sponsor ^†	Rigshospitalet, Denmark
Collaborators ^††
Investigators ^†	Principal Investigator: Gedske Daugaard, M.D., DMSc, Rigshospitalet, Denmark
Information Provided By	Rigshospitalet, Denmark
Verification Date	February 2012
First Received Date ^†	May 8, 2006
Last Updated Date	February 20, 2012

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.