Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

NCT ID: NCT00324012

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2012-02-29

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

Conditions

Adrenocortical Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment

taxotere and cisplatin day one every three weeks

Group Type: EXPERIMENTAL

cisplatin, taxotere

Intervention Type: DRUG

cisplatin 75 mg/m2 Taxotere 75 mg/m2

Interventions

cisplatin, taxotere

cisplatin 75 mg/m2 Taxotere 75 mg/m2

Intervention Type: DRUG

Other Intervention Names

docetaxel

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Gedske Daugaard

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gedske Daugaard, M.D., DMSc

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Department of Oncology 5073, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

02 262098

Identifier Type: -

Identifier Source: org_study_id