Diarrhea Clinical Trial
Official title:
A Phase II Clinical Trial of Cabazitaxel Plus Prednisone With Octreotide in the Treatment of Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel
Verified date | November 2014 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 9 |
Est. completion date | November 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | USC/Norris Comprehensive Cancer Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | National Cancer Institute (NCI), Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of Grade 2 plus diarrhea | Defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 criteria as an increase in frequency of 4 or greater stools per day over baseline, incontinence, diarrhea warranting hospitalization or diarrhea limiting self-care activities of daily living (ADL). Baseline frequency will be defined in the pre-treatment assessment from cycle 1 as the maximum number of stools in one 24 hour period during the past 2 weeks. Any incidence of grade 2 or greater diarrhea during treatment or for up to 21 days after the last administration of cabazitaxel will be included in this endpoint. | Baseline through 21 days after the last administration of cabazitaxel | No |
Secondary | Progression-Free Survival | At 1 month after completion of treatment, every 3 months until disease progression, and then every 6 months thereafter | No | |
Secondary | Overall Survival | At 1 month after completion of treatment, every 3 months until disease progression, and then every 6 months thereafter | No | |
Secondary | RECIST response for patients with measurable disease | Baseline, after every 4 courses, at the end of treatment, and then every 6 months | No | |
Secondary | Prostate-Specific Antigen response | Baseline, day 1 of each course, at the end of treatment, and then every 6 months | No | |
Secondary | Pain palliation in patients with a baseline pain score greater or equal to 2 | Baseline, day 1 of each 3 week course, at the end of treatment, and then every 6 months for up to 52 weeks | No | |
Secondary | Toxicity (adverse events considered to be at least possibly drug-related) | Baseline, day 1 of each course, and at the end of treatment | Yes |
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