Carboplatin, Everolimus, and Prednisone in Treating Patients With Metastatic Prostate Cancer That Progressed After Docetaxel
NCT ID: NCT01051570
Last Updated: 2020-12-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2010-02-28
2013-09-30
Brief Summary
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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.
Detailed Description
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Primary
* To evaluate the time to progression (TTP) achieved with carboplatin and everolimus in patients with castrate resistant metastatic prostate cancer that progressed after docetaxel-based chemotherapy.
Secondary
* To evaluate the safety of this regimen.
* To assess the PSA response rate in patients treated with this regimen.
* To evaluate the overall survival (OS) outcome in these patients.
* To investigate the association of TTP and PSA response rate with correlative markers, such as phospho mTOR, pAKT, and p70S6.
* To evaluate the pharmacokinetics of this regimen.
* To explore the association of TTP, OS, and circulating tumor tumor cell count.
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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Carboplatin, RAD 001 & Prednisone
Carboplatin: AUC=4 by Calvert's formula (max dose 600 mg)\*IV over 30-60 min, Day 1 of a 21 day cycle
RAD 001: 5 mg Orally daily, starting from Day 2 continuously
Prednisone 5 mg Orally twice daily, continuously
carboplatin
AUC = 5 by Calvert's formula, day 1 of each 21 day cycle
RAD 001
5 mg orally starting on Day 2 then continuous
prednisone
5 mg orally twice a day starting on Day 1 then continuous
laboratory biomarker analysis
Samples will be collected from archival tissue.
pharmacological study
Samples will be collected Cycle 1, day 1, 2 \& 8 and Cycle 2, Day 1 \& 2
Interventions
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carboplatin
AUC = 5 by Calvert's formula, day 1 of each 21 day cycle
RAD 001
5 mg orally starting on Day 2 then continuous
prednisone
5 mg orally twice a day starting on Day 1 then continuous
laboratory biomarker analysis
Samples will be collected from archival tissue.
pharmacological study
Samples will be collected Cycle 1, day 1, 2 \& 8 and Cycle 2, Day 1 \& 2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
* NYHA class III-IV symptomatic congestive heart failure
* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within the past 6 months, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
* Severely impaired lung function as defined by spirometry and DLCO that is 50% of the normal predicted value and/or oxygen saturation that is ≤ 88% at rest on room air
* Uncontrolled diabetes as defined by fasting serum glucose \> 1.5 times ULN
* Liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
* Known history of HIV seropositivity, hepatitis B or C
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
* Active, bleeding diathesis
* 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
* Docetaxel based combination therapy or docetaxel alone considered as 1 regimen
* 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
* Topical or inhaled corticosteroids are allowed
* No concurrent prophylactic growth factors
* Concurrent bisphosphonate therapy allowed
18 Years
120 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Barbara Ann Karmanos Cancer Institute
OTHER
Responsible Party
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Elisabeth Heath
Principal Investigator
Principal Investigators
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Ulka N. Vaishampayan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Locations
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Northshore University Health System
Evanston, Illinois, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Countries
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References
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Vaishampayan U, Shevrin D, Stein M, Heilbrun L, Land S, Stark K, Li J, Dickow B, Heath E, Smith D, Fontana J. Phase II Trial of Carboplatin, Everolimus, and Prednisone in Metastatic Castration-resistant Prostate Cancer Pretreated With Docetaxel Chemotherapy: A Prostate Cancer Clinical Trial Consortium Study. Urology. 2015 Dec;86(6):1206-11. doi: 10.1016/j.urology.2015.08.008. Epub 2015 Sep 12.
Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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WSU-2009-087
Identifier Type: -
Identifier Source: secondary_id
NOVARTIS-WSU-2009-087
Identifier Type: -
Identifier Source: secondary_id
CDR0000663630
Identifier Type: -
Identifier Source: org_study_id