Status:
COMPLETED
Study Combining Imatinib Mesylate (Gleevec) With Sorafenib in Patients With Androgen-independent Prostate Cancer (AIPC)
Lead Sponsor:
Oncology Specialists, S.C.
Conditions:
Prostate Cancer
Eligibility:
MALE
18-90 years
Phase:
PHASE1
Brief Summary
Eligible patients will be enrolled in one of 4 cohorts where each cohort will allow 3 patients to be on study. Patients will receive both study drugs on escalated dosing schedule until the maximum of ...
Detailed Description
Gleevec and Sorafenib have modest efficacy in androgen-independent prostate cancer (AIPC) and the fact that both agents can be given orally with what appears to be tolerable side effects, we hypothesi...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older.
- Histologically documented diagnosis of Prostate Cancer regardless of Gleason score.
- Androgen-Independent Prostate Cancer
- At least one measurable site of disease
- Patients must have failed one or more lines of systemic chemotherapy, regardless of the chemotherapeutic agent used. There is NO limit to how many lines of chemotherapy a patient can receive
- Patients receiving anti-coagulation treatment with an agent such as heparin may be allowed to participate. Patients on Warfarin are NOT allowed to participate.
- Last chemotherapy exposure 4 weeks prior to study entry
- Prior exposure to Sorafenib is allowed as long as last Sorafenib dose was 3 weeks or more from study entry
- Prior exposure to Gleevec is an EXCLUSION
- Progression after chemotherapy can be demonstrated radiographically (as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria) or biochemically with prostate-specific antigen (PSA) being elevated more than 25% than previous value as long as a repeat PSA confirms progression. (repeat PSA should be done within 3 weeks from the last one). Patients with bone-only disease are considered progressing if there are two more lesions on a new bone scan.
- Performance status 0,1, 2 (ECOG)
- Adequate end organ function, defined as the following:
- total bilirubin \< 1.5 x Upper Limit of Normal (ULN), serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) \< 2.5 x Upper Limit of Normal (UNL), creatinine \< 1.5 x Upper Limit of Normal (ULN), absolute neutrophil count (ANC) \> 1.0 x 109/L, platelets \> 75 x 109/L.
- Men of childbearing potential must agree to employ an effective barrier method of birth control prior to the study entry, throughout the duration of the study and for up to 3 months following discontinuation of study drug.
- Written, voluntary informed consent.
- Patients are allowed the following concurrent therapies:
- Intravenous bisphosphonates if administered for bone metastases
- luteinizing hormone releasing hormone (LHRH) analogues
- Narcotic-type medical interventions to control malignancy-related pain
Exclusion
- Patient has received any other investigational agents within 21 days of first day of study drug dosing, unless the disease is rapidly progressing.
- Patient is \< 3 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal or squamous cell skin cancer. Existence of any other malignant disease is not allowed.
- Patient with Grade III/IV cardiac problems
- Patient has a severe and/or uncontrolled medical disease
- Patient has a known brain metastasis.
- Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event \> Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Use of St. John's Wort or rifampin (rifampicin).
- Any condition that impairs patient's ability to swallow whole pills.
- Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
- Patient previously received radiotherapy to ³ 25 % of the bone marrow
- Patient had a major surgery within 2 weeks prior to study entry.
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00424385
Start Date
January 1 2007
End Date
February 1 2012
Last Update
July 21 2014
Active Locations (2)
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1
Oncology Specialists, S.C
Niles, Illinois, United States, 60714
2
Oncology Specialists, S.C
Park Ridge, Illinois, United States, 60068