Trial record 5 of 46 for:    "Adrenocortical carcinoma"

Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gedske Daugaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00324012
First received: May 8, 2006
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Adrenocortical Carcinoma
Drug: cisplatin, taxotere
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • response rate [ Time Frame: in months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival, time to progression, best overall response rate and duration of response [ Time Frame: survival at 6 months and 1 year ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2006
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
taxotere and cisplatin day one every three weeks
Drug: cisplatin, taxotere
cisplatin 75 mg/m2 Taxotere 75 mg/m2
Other Name: docetaxel

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324012

Locations
Denmark
Department of Oncology 5073, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Gedske Daugaard, M.D., DMSc Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Gedske Daugaard, Associate professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00324012     History of Changes
Other Study ID Numbers: 02 262098
Study First Received: May 8, 2006
Last Updated: February 20, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
Adrenocortical Carcinoma
cisplatin
taxotere

Additional relevant MeSH terms:
Adrenocortical Carcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014