Overview

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

Status:
Terminated
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
Male
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 docetaxel. Octreotide may prevent diarrhea by blocking the secretion of several hormones in patients receiving chemotherapy for prostate cancer
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Southern California
Collaborators:
National Cancer Institute (NCI)
Sanofi
Treatments:
Docetaxel
Octreotide
Prednisone
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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