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RATIONALE: Drugs used in chemotherapy, such as carboplatin and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving carboplatin together with everolimus and prednisone may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin together with everolimus and prednisone works in treating patients with metastatic prostate cancer that progressed after docetaxel.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive carboplatin IV over 30-60 minutes on day 1, oral prednisone twice daily on days on days 1-21, and oral everolimus once daily on days 2-21 of course 1 and on days 1-21 of subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected periodically for pharmacodynamic, pharmacokinetic, and biomarker analysis.
After completion of study treatment, patients are followed up every 3 months.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic adenocarcinoma of the prostate
Objective disease progression or rising PSA despite androgen deprivation therapy and antiandrogen withdrawal (when applicable)
Progressed after ≥ 1 prior docetaxel-based chemotherapy regimen for metastatic disease
Patients with measurable disease* must have either rising PSA, increase in size of the lesion(s), or both
Patients with no measurable disease must have a PSA ≥ 5 ng/mL or new areas of bony metastases on bone scan NOTE: *There is no minimum PSA requirement for patients with measurable disease
Documented to be castrate with a testosterone level of ≤ 0.5 ng/mL
No uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Zubrod performance status 0-1
ANC ≥ 1,500/mm^3
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/mm^3
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
Calculated creatinine clearance ≥ 50 mL/min OR serum creatinine ≤ 2 mg/dL
AST and/or ALT ≤ 2.5 times ULN if alkaline phosphatase normal OR alkaline phosphatase ≤ 4 times ULN if AST and/or ALT normal (for patients without documented bone metastases or for patients with liver metastases)
AST and/or ALT < 2.5 times ULN, without regard to alkaline phosphatase levels (for patients with documented bone metastases)
Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 times ULN (in the case that one or both of these thresholds are exceeded, the patient is eligible only after initiation of appropriate lipid-lowering medication)
Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
Willing and able to comply with this study
Able to ingest oral medication
No other malignancies except non-melanoma skin cancer or any other adequately treated cancer in complete remission for ≥ 2 years
No significant traumatic injury within the past 4 weeks
No active (acute or chronic) or uncontrolled severe infections
No severe and/or uncontrolled medical conditions or other conditions that could affect study participation, including the following:
No known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients
No history of noncompliance to medical regimens
No uncontrolled diabetes mellitus
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 1 prior docetaxel based regimen for metastatic disease
No more than 2 prior chemotherapy regimens for metastatic disease
No prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)
At least 6 weeks since prior bicalutamide or nilutamide
At least 4 weeks since prior flutamide
More than 4 weeks since prior and no other concurrent investigational drugs
More than 4 weeks since prior and no other concurrent anticancer therapies (including chemotherapy, radiotherapy, or antibody-based therapy)
More than 4 weeks since prior and no concurrent major surgery (defined as requiring general anesthesia) and recovered
More than 1 week since prior and no concurrent immunization with attenuated live vaccines
No concurrent chronic, systemic treatment with corticosteroids or other immunosuppressive agents
No concurrent prophylactic growth factors
Concurrent bisphosphonate therapy allowed
Primary purpose
Allocation
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26 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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