Status:
COMPLETED
Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)
Lead Sponsor:
Collaborative Group for Adrenocortical Carcinoma Treatment
Collaborating Sponsors:
German Federal Ministry of Education and Research
National Cancer Institute (NCI)
Conditions:
Carcinoma, Adrenal Cortical
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether treatment with etoposide, doxorubicin, cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane (Sz/M) in patients ...
Detailed Description
The Firm-ACT trial is the first ever conducted randomized controlled phase III trial in adrenocortical carcinoma (ACC), a rare malignancy with poor prognosis. It will provide results leading to the es...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of adrenocortical carcinoma
- Locally advanced or metastatic disease not amenable to radical surgery resection (Stage III-IV)
- Radiologically monitorable 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
- 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 ≤ 50 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
- Decompensated heart failure (ejection fraction \<50%), myocardial infarction or revascularization procedure during the last 6 months, unstable angina pectoris, and uncontrolled cardiac arrhythmia
- Current treatment with other experimental drugs and/or previous participation in clinical trials with other experimental agents for adrenocortical carcinoma
- Prisoners
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00094497
Start Date
June 1 2004
End Date
December 1 2010
Last Update
September 21 2016
Active Locations (32)
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1
National Cancer Institute - Center for Cancer Research
Bethesda, Maryland, United States
2
University of Michigan, Department of Internal Medicine
Ann Arbor, Michigan, United States, 48109
3
Royal Adelaide Hospital
Adelaide, Australia, SA 5000
4
University of Graz
Graz, Austria, 8036