Status:
COMPLETED
Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Prostate Cancer
Stage I Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well lapatinib ditosylate works in treating patients with a rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that prostate cance...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the percentage of patients with hormone sensitive prostate cancer who experience \> 50% decline in serum PSA during treatment with GW572016 (lapatinib ditosylate). ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed diagnosis of prostate cancer
- Previous treatment with definitive surgery or radiation therapy
- Prior salvage therapy (surgery, radiation, or other local ablative procedures) is allowed if the intent was for cure
- No evidence of metastatic disease on physical exam, computed tomography (CT) (magnetic resonance imaging \[MRI\]), and bone scan
- Prior neoadjuvant/adjuvant hormonal or chemotherapy and investigational agents are allowed if it was last used \>= 1 year prior to enrollment (no prior vaccine/immunotherapy for prostate cancer will be allowed)
- No therapy modulating testosterone levels (such as luteinizing-hormone releasing-hormone agonists/antagonists and antiandrogens) is permitted within 1 year prior to enrollment; agents such as 5alpha-reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, or herbal supplements are not permitted at any time during the period that the PSA values are being collected
- Hormone-sensitive prostate cancer as evident by a serum total testosterone level \> 150 ng/dL within 4 weeks prior to registration
- All patients must have evidence of biochemical progression as determined by a reference PSA value followed by 2 rising PSA values, each higher than the previous value, obtained at least 6 weeks apart; all of these PSA values must be obtained at the same reference lab, and all must be done within 6 months prior to enrollment
- The most recent of the PSA values must be greater than 0.4 ng/ml (after prostatectomy) or greater than 1.5 ng/ml (after radiation therapy) at time of enrollment; this measurement must be obtained within 6 months prior to enrollment
- PSA doubling time (PSADT) must be =\< 365 days
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Leukocytes \>= 3000/mm\^3
- Granulocytes \>= 1500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Serum creatinine within normal institutional limits or creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Serum total bilirubin within normal institutional limits
- Serum alkaline phosphatase within normal institutional limits
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x institutional upper limit of normal
- Cardiac ejection fraction within the institutional range of normal, as measured by echocardiogram or multi gated acquisition scan (MUGA) scan within 4 weeks prior to registration; note that baseline and on-treatment scans should be performed using the same modality and preferably at the same institution
- No unstable arrhythmias on electrocardiogram (ECG) are allowed (rate controlled, asymptomatic atrial fibrillation is allowed)
- No concomitant use of any medication classified as cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducer or inhibitor; for patients previously treated with one of these prohibited medications, the prohibited agent needs to be discontinued, either 7 days, 14 days, or 6 months prior to the administration of the first dose of study medication
- Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
- Normal prothrombin time (PT)/international normalized ratio (INR) within 4 weeks prior to registration
- Able to swallow and retain oral medication
- Patients with gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis) will not be eligible
- Sexually active males are strongly advised to use an accepted and effective method of contraception
- Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016
- No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- No other malignancies permitted within the past 5 years with the exception of non-melanoma skin cancer treated with curative intent
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00103194
Start Date
September 1 2005
End Date
June 1 2013
Last Update
September 30 2014
Active Locations (1)
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1
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States, 19103