Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chem… (NCT01313559) | Clinical Trial Compass
TerminatedPhase 2
Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
Stopped: Slow accrual
United States6 participantsStarted 2011-06
Plain-language summary
This is an open label randomized phase II study for prostate cancer patients who have disease progression after hormonal therapy. SOM230 LAR (Pasireotide) binds to its receptor of prostate cancer cells and can prevent them from growing. Everolimus works by targeting a cell survival factor in prostate cancer. The combination of these drugs may work better for the treatment of prostate cancer without toxic chemotherapy. Patients will receive either SOM230 LAR (group A) or SOM230 LAR in combination with Everolimus (group B).
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Age minimum: 18 years old
* Histological confirmation of prostatic adenocarcinoma
* PSA \> or = to 2 ng/ml
* PSA progression (serially rises on two occasions each at least one week apart) OR disease progression on imaging studies (CT scan or bone scan).
* Minimally symptomatic - no symptoms attributed to prostate cancer greater than Grade I based on NCI CTCAE Version 4.0 grading of toxicities
* Discontinuation of all antiandrogen, ketoconazole and investigational drugs for at least 4 weeks (6 weeks for bicalutamide) prior to study initiation
* Maintain castrate levels of testosterone (\<50ng/dL)
* Karnofsky Performance Status \> or = to 60%
* Life expectancy \> 3 months
* Adequate hematologic, renal, and liver function
Exclusion Criteria:
* Currently active second malignancy other than non-melanoma skin cancers.
* Clinically significant cardiovascular disease: EF \< 30%, NHYA Class III or greater congestive heart failure, myocardial infarction/unstable angina within 6 months prior to study enrollment, or significant ECG abnormalities such as QRS/QT prolongation (see Section 5.3).
* Progressive pulmonary disease, such as advanced COPD, pulmonary fibrosis, or supplemental O2 requirement.
* Known CNS disease, except for treated brain metastases.
* Poorly controlled diabetes mellitus (HbA1c \> 7 %) or fasting blood glucose level \>126 mg/dL in non-diabetic patients or \> 189 mg/dL in diabetic patients (can be enrolled after initiation or titration of anti…
What they're measuring
1
Number of Participants Alive and Progression Free After 12 Weeks of Treatment
Timeframe: 12 weeks after treatment
Trial details
NCT IDNCT01313559
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University