Status:
TERMINATED
Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Sanofi
Conditions:
Diarrhea
Hormone-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well octreotide works in reducing diarrhea in patients receiving cabazitaxel and prednisone for hormone-resistant prostate cancer (HRPC) previously treated with docetax...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the impact of octreotide in reducing the incidence of grade 2 or greater diarrhea in men receiving cabazitaxel plus prednisone for castration-resistant prostate can...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed prostate cancer
- Measurable disease on computed tomography (CT) or evaluable disease with an elevated PSA
- Documented progression on (a) at least one prior hormone treatment, which must have incorporated luteinizing hormone-releasing hormone (LHRH) agonist therapy AND (b) at least one chemotherapy regimen, which must have included docetaxel; progression may be demonstrated by radiologic criteria or by PSA only if accompanied by new or worsening symptoms (pain progression)
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
- Absolute neutrophil count (ANC) more than or equal to 1500/ul
- Hemoglobin more than or equal to 8.0 g/dL
- Platelet count more than or equal to 100,000/ul
- Serum creatinine less than or equal to 1.5x the upper limit of normal (ULN)
- Bilirubin less than or equal to ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 1.5x ULN
- Must be recovered from acute and late effects of any prior surgery, radiotherapy or other anti-neoplastic therapy
- Patients or their legal representatives must be able to read, understand, and provide informed consent
- Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter
- Palliative radiation for metastatic disease is allowed if less or equal to 40% of the total bone marrow was irradiated; 28 days must have elapsed since completion of radiation therapy (RT) with bone marrow recovery; soft tissue disease irradiated in the prior 2 months may not be designated as measurable disease
- Concomitant bisphosphonate use is permitted if the dose had been stable for 12 weeks prior to enrollment
Exclusion
- Treatment with radiotherapy, chemotherapy or any investigational agent in the prior 4 weeks
- Major surgery in the prior 4 weeks
- Prior treatment with cabazitaxel
- Patients with known hypersensitivity to cabazitaxel, other drugs formulated with polysorbate 80 or octreotide
- Inability to tolerate oral prednisone
- Grade 2 or greater diarrhea in the prior 2 weeks
- Grade 2 or greater neuropathy or stomatitis
- Presence of an active uncontrolled infection or fever greater or equal to 38.5 degrees
- Presence of parenchymal brain metastases; patients with neurological symptoms must have a CT or magnetic resonance imaging (MRI) of the brain showing no metastases within 60 days of enrollment
- Prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage I or stage II cancer in complete remission for at least 12 months
- History of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure (CHF) or recent myocardial infarction (MI)within 6 months of enrollment
- Known human immunodeficiency virus (HIV) or hepatitis infection
- Life expectancy less than 3 months
- Presence of any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with interpretation of the results
- Lack of ability/willingness to give informed consent
- Lack of ability/willingness to receive octreotide injection
- Anticipated non-availability for study visits/procedures
- Patients with uncontrolled diabetes, defined as a HbA1c greater than 7% or greater or equal to 8% despite therapy, or a fasting plasma glucose more than 2x ULN; at the investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01469338
Start Date
July 1 2012
End Date
November 1 2014
Last Update
November 24 2014
Active Locations (1)
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1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033