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Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adrenocortical Carcinoma

Intervention: cisplatin, taxotere (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Rigshospitalet, Denmark

Official(s) and/or principal investigator(s):
Gedske Daugaard, M.D., DMSc, Principal Investigator, Affiliation: Rigshospitalet, Denmark

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.

Clinical Details

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

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

Primary outcome: response rate

Secondary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Department of Oncology 5073, Rigshospitalet, Copenhagen 2100, Denmark
Additional Information

Starting date: April 2006
Last updated: February 20, 2012

Page last updated: August 23, 2015

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