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Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

Primary Purpose

Adrenocortical Carcinoma

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
cisplatin, taxotere
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adrenocortical Carcinoma focused on measuring Adrenocortical Carcinoma, cisplatin, taxotere

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Oncology 5073, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

taxotere and cisplatin day one every three weeks

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

Survival, time to progression, best overall response rate and duration of response

Full Information

First Posted
May 8, 2006
Last Updated
February 20, 2012
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00324012
Brief Title
Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma
Official Title
Phase II Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenocortical Carcinoma
Keywords
Adrenocortical Carcinoma, cisplatin, taxotere

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
taxotere and cisplatin day one every three weeks
Intervention Type
Drug
Intervention Name(s)
cisplatin, taxotere
Other Intervention Name(s)
docetaxel
Intervention Description
cisplatin 75 mg/m2 Taxotere 75 mg/m2
Primary Outcome Measure Information:
Title
response rate
Time Frame
in months
Secondary Outcome Measure Information:
Title
Survival, time to progression, best overall response rate and duration of response
Time Frame
survival at 6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gedske Daugaard, M.D., DMSc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology 5073, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

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