Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

Adrenocortical Carcinoma Clinical Trial

Official title:

Phase II Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324012
• Other study ID #: 02 262098
• Status: Completed
• Phase: Phase 2
• First received: May 8, 2006
• Last updated: February 20, 2012
• Start date: April 2006
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenocortical Carcinoma
• Carcinoma

Intervention

Drug:
• cisplatin, taxotere
cisplatin 75 mg/m2 Taxotere 75 mg/m2

Locations

Country	Name	City	State
Denmark	Department of Oncology 5073, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		in months	No
Secondary	Survival, time to progression, best overall response rate and duration of response		survival at 6 months and 1 year	No