Status:
COMPLETED
Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Adrenocortical Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 re...
Detailed Description
Treatment every three weeks, evaluation after 2 cycles, CTC criterias used for toxicity evaluation
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00324012
Start Date
April 1 2006
End Date
February 1 2012
Last Update
February 22 2012
Active Locations (1)
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1
Department of Oncology 5073, Rigshospitalet
Copenhagen, Denmark, 2100