Status:
TERMINATED
IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Adrenocortical Carcinoma
Stage III Adrenocortical Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial is studying mitotane and IMC-A12 to see how well they work compared with mitotane alone in treating patients with recurrent, metastatic, or primary adrenocortical cancer...
Detailed Description
PRIMARY OBJECTIVES: I. Compare the progression-free survival (PFS) rate in patients with recurrent, metastatic, or primary unresectable adrenocortical carcinoma treated with mitotane with vs without ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed adrenocortical carcinoma
- Documented unresectable recurrent, unresectable advanced, or metastatic disease
- At least 1 lesion that can be accurately measured by RECIST criteria as ≥ 20 mm by conventional radiologic techniques or as ≥ 10 mm by spiral CT scan or MRI
- Patients with disease in an irradiated field as the only site of measurable disease allowed provided there has been a clear progression of the lesion
- No tumors potentially resectable by surgical excision alone
- No known or suspected leptomeningeal disease or brain metastases
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL (transfusion allowed)
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 60 mL/min
- AST or ALT ≤ 3 times ULN
- Total bilirubin ≤ 1.5 times ULN
- HbA1c \< 8 within the past 4 weeks
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- Able to take oral medications
- No poor gastrointestinal absorption
- Patients with diabetes mellitus are eligible provided they meet all of the following criteria:
- Blood glucose is normal (random glucose ≤ 150 mg/dL)
- HgbA1c ≤ 8 within the past 4 weeks
- On a stable dietary or therapeutic regimen for the past 2 months
- No active uncontrolled infection
- No severe disease or condition that, in the judgement of the investigator, would make the patient inappropriate for study participation, including, but not limited to:
- Bleeding diathesis
- Uncontrolled chronic kidney or liver disease
- Uncontrolled diabetes
- History of cardiac history
- Myocardial infarction within the past 6 months
- Congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Uncontrolled hypertension
- No current malignancy or previous malignancy with a disease-free interval of \< 2 years at the time of diagnosis
- Patients with adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or skin, or stage A low-grade prostate cancer are eligible
- No known hypersensitivity to monoclonal antibody therapy or mitotane
- No known HIV or hepatitis B or C infection
- No serious medical or psychiatric disorder that would interfere with patient safety or informed consent
- All significant toxic effects of prior surgery resolved to ≤ grade 1 according to NCI CTCAE v. 3.0 criteria
- Mitotane for \< 8 weeks prior to study entry AND tolerated it well
- No prior IGFR-directed therapy
- No prior systemic antitumor therapy (cytotoxic chemotherapy, biologic, immunotherapy, or targeted therapy)
- Prior incomplete surgical resections or radiofrequency ablation or radiotherapy will not be considered as prior therapy provided measurable sites of disease remain
- Prior adjuvant chemotherapy or mitotane will not be considered as prior antitumor therapy unless it was completed \< 6 months before study enrollment
- No prior radiotherapy to \> 20% of bone marrow
- More than 4 weeks since prior and no concurrent radiotherapy
- Radiotherapy for palliation of symptoms related to metastases is permitted provided that it is \> 4 weeks from study initiation, and does not involve target/measureable lesions that are followed for drug treatment response evaluation
- No concurrent mitotane ≥ 8 weeks prior to study
- No concurrent tumor resection or tumor-directed surgery
- No other concurrent anticancer or investigational therapy
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00778817
Start Date
December 1 2008
End Date
March 1 2014
Last Update
April 29 2014
Active Locations (8)
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1
University of Southern California
Los Angeles, California, United States, 90033-0804
2
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
3
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
4
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 60702