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