Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

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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

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
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

response rate

Secondary Outcome

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

Condition

Adrenocortical Carcinoma

Intervention

cisplatin, taxotere

Study Arms / Comparison Groups

 treatment
Description:  taxotere and cisplatin day one every three weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

19

Start Date

April 2006

Completion Date

February 2012

Primary Completion Date

February 2012

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gedske Daugaard, M.D., DMSc, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT00324012

Organization ID

02 262098


Responsible Party

Principal Investigator

Study Sponsor

Rigshospitalet, Denmark


Study Sponsor

Gedske Daugaard, M.D., DMSc, Principal Investigator, Rigshospitalet, Denmark


Verification Date

February 2012