Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

Stopped early · Phase 2

Conditions studied: Diarrhea, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer

In brief

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 docetaxel. Octreotide may prevent diarrhea by blocking the secretion of several hormones in patients receiving chemotherapy for prostate cancer

Key facts

Study ID

NCT01469338

Run by

University of Southern California

People needed

9

Starts

2012-07-01

Expected to finish

2014-11-01

Last updated by the study team

2014-11-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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