Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma

NCT00324012 | Completed Phase 2

• 1 other identifier: 02 262098
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenocortical Carcinoma

Keywords

Adrenocortical Carcinoma; cisplatin; taxotere

Outcome Measures

Primary Outcomes (1)

• response rate

  in months

Secondary Outcomes (1)

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

  survival at 6 months and 1 year

Study Arms (1)

treatment

EXPERIMENTAL

taxotere and cisplatin day one every three weeks

Drug: cisplatin, taxotere

Interventions

cisplatin, taxotere DRUG

cisplatin 75 mg/m2 Taxotere 75 mg/m2

Also known as: docetaxel

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Oncology 5073, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Adrenocortical Carcinoma

Interventions

Cisplatin; Docetaxel

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Gedske Daugaard, M.D., DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 10, 2006
• Study Start: April 1, 2006
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

DK (1)