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Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00324012
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):
Gedske Daugaard, Rigshospitalet, Denmark

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 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.

Condition or disease Intervention/treatment Phase
Adrenocortical Carcinoma Drug: cisplatin, taxotere Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma
Study Start Date : April 2006
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: treatment
taxotere and cisplatin day one every three weeks
Drug: cisplatin, taxotere
cisplatin 75 mg/m2 Taxotere 75 mg/m2
Other Name: docetaxel

Primary Outcome Measures :
  1. response rate [ Time Frame: in months ]

Secondary Outcome Measures :
  1. Survival, time to progression, best overall response rate and duration of response [ Time Frame: survival at 6 months and 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00324012

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Department of Oncology 5073, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Gedske Daugaard, M.D., DMSc Rigshospitalet, Denmark
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Responsible Party: Gedske Daugaard, Associate professor, Rigshospitalet, Denmark Identifier: NCT00324012    
Other Study ID Numbers: 02 262098
First Posted: May 10, 2006    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by Gedske Daugaard, Rigshospitalet, Denmark:
Adrenocortical Carcinoma
Additional relevant MeSH terms:
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Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action