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

Phase 2
18 Years
Not Enrolling
Adrenocortical Carcinoma

Thank you

Trial Information

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

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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

response rate

Outcome Time Frame:

in months

Safety Issue:


Principal Investigator

Gedske Daugaard, M.D., DMSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rigshospitalet, Denmark


Denmark: Danish Medicines Agency

Study ID:

02 262098



Start Date:

April 2006

Completion Date:

February 2012

Related Keywords:

  • Adrenocortical Carcinoma
  • Adrenocortical Carcinoma
  • cisplatin
  • taxotere
  • Carcinoma
  • Adrenocortical Carcinoma