Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma
This study has been completed.
Sponsor:
Rigshospitalet, Denmark
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
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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 May 22, 2013