Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial to Establish the Safety and Preliminary Efficacy of the Combination of Docetaxel, Prednisone, and SOM 230 (Pasireotide) in Metastatic Castrate Resistant Prostate Cancer (CRPC).|
- Occurrence of adverse events and the associated grade per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 to identify the maximum tolerated dose (MTD) of pasireotide in combination with docetaxel and prednisone [ Time Frame: Up to day 57 ]The occurrence rate of binary endpoints (eg, specific types of toxicity at a certain dose level and severity grade, response, etc) will be described by point estimates and exact 90% confidence intervals (CIs) for proportions using Wilson's method.
- All specific types of toxicity as assessed via NCI CTCAE version 4.0 [ Time Frame: On days 1, 8, 15, 22, 29, 36 43, 50 and 57 ]
- Measurements of tumor using Response Evaluation Criteria In Solid Tumors (RECIST) criteria before and after treatment with the combination of pasireotide in combination with docetaxel [ Time Frame: Every 12 weeks for the first 36 weeks and then every 16 weeks thereafter ]
- Percentage prostate-specific antigen (PSA) decline noted [ Time Frame: On days 1, 8, 15, 22, 29, 36 43, 50 and 57 ]
- Time to Progression (TTP) [ Time Frame: Every 3 months for the first 9 months on study then every 4 months after the first 9 months on study ]
- Overall Survival (OS) [ Time Frame: Every 3 months for the first 9 months on study then every 4 months after the first 9 months on study ]
- Pharmacokinetics (PK) parameters [ Time Frame: Predosing/end of infusion/2, 3, 4 ,7, 24 and 48 hours after start of docetaxel; Day 43; predosing for docetaxel and pasireotide/end of infusion/2, 3, 4, 7, 24 hours day 44/48 hours day 45 after start of infusion; days 29, 57, and 85 prior to pasireotide ]
- Measurement of levels of IGF-1, serum chromogranin A (SCA), and neuron specific enolase (NSE), pre-therapy, post-therapy, and the change between time points and association with duration of TTP and OS [ Time Frame: Baseline and days 22 and 43 ]
- Measurements of CTC counts pre-therapy, post-therapy, and the change between time-points and association with duration of TTP and OS [ Time Frame: Baseline and days 22 and 43 ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy, receptor agonist)
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: pasireotide
Other Name: SOM230Drug: prednisone
I. To establish the maximum tolerated dose (MTD) level of SOM 230 (pasireotide) in combination with docetaxel and prednisone.
I. To evaluate the safety and tolerability of the combination in metastatic castration-resistant prostate cancer (CRPC).
II. To evaluate preliminary efficacy of the combination of SOM 230 and docetaxel and prednisone as defined by response rates (measurable and prostate-specific antigen [PSA]), time to progression (TTP) and overall survival (OS).
III. To evaluate the pharmacokinetics (PK) of the combination. IV. To assess the pharmacodynamic (PD) effects of the combination as seen by baseline levels of and changes in insulin-like growth factor (IGF)-1, serum chromogranin A (SCA), and neuron specific enolase (NSE), and to associate them with TTP and OS.
V. To assess the pretherapy circulating tumor cell (CTC) counts and change in CTC after therapy, and to associate them with TTP and OS.
OUTLINE: This is a phase I dose-escalation study of pasireotide followed by a phase II study.
Patients receive pasireotide intramuscularly (IM) on day 1, docetaxel intravenously (IV) over 1 hour, and prednisone orally (PO) twice daily (BID) continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 28 days and then every 3 months thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468532
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Ulka Vaishampayan||Barbara Ann Karmanos Cancer Institute|