A Phase II Clinical Trial of Cabazitaxel Plus Prednisone With Octreotide in the Treatment of Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Development of Grade 2 plus diarrhea
研究概览
简要总结
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
详细描述
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 cancer (CRPC) after docetaxel therapy.
SECONDARY OBJECTIVES:
I. Overall survival (OS).
II. Progression-free survival (PFS) (defined as the time between treatment start and the first date of progression as measured by objective tumor progression using the Response Evaluation Criteria In Solid Tumors (RECIST), pain progression or death).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Supportive care (management of therapy complications)
Patients receive cabazitaxel IV over 1 hour on day 1, prednisone PO QD, and octreotide pamoate IM on day 1. Patients also receive octreotide acetate SC TID on days 1-14 of course 1 only. Treatment with cabazitaxel repeats every 21 days and treatment with prednisone and octreotide pamoate repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
干预措施: cabazitaxel (Drug)
Supportive care (management of therapy complications)
Patients receive cabazitaxel IV over 1 hour on day 1, prednisone PO QD, and octreotide pamoate IM on day 1. Patients also receive octreotide acetate SC TID on days 1-14 of course 1 only. Treatment with cabazitaxel repeats every 21 days and treatment with prednisone and octreotide pamoate repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
干预措施: prednisone (Drug)
Supportive care (management of therapy complications)
Patients receive cabazitaxel IV over 1 hour on day 1, prednisone PO QD, and octreotide pamoate IM on day 1. Patients also receive octreotide acetate SC TID on days 1-14 of course 1 only. Treatment with cabazitaxel repeats every 21 days and treatment with prednisone and octreotide pamoate repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
干预措施: octreotide pamoate (Drug)
Supportive care (management of therapy complications)
Patients receive cabazitaxel IV over 1 hour on day 1, prednisone PO QD, and octreotide pamoate IM on day 1. Patients also receive octreotide acetate SC TID on days 1-14 of course 1 only. Treatment with cabazitaxel repeats every 21 days and treatment with prednisone and octreotide pamoate repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
Supportive care (management of therapy complications)
Patients receive cabazitaxel IV over 1 hour on day 1, prednisone PO QD, and octreotide pamoate IM on day 1. Patients also receive octreotide acetate SC TID on days 1-14 of course 1 only. Treatment with cabazitaxel repeats every 21 days and treatment with prednisone and octreotide pamoate repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
干预措施: octreotide acetate (Drug)
结局指标
主要结局
Development of Grade 2 plus diarrhea
时间窗: Baseline through 21 days after the last administration of cabazitaxel
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.
次要结局
- Prostate-Specific Antigen response(Baseline, day 1 of each course, at the end of treatment, and then every 6 months)
- Progression-Free Survival(At 1 month after completion of treatment, every 3 months until disease progression, and then every 6 months thereafter)
- Overall Survival(At 1 month after completion of treatment, every 3 months until disease progression, and then every 6 months thereafter)
- RECIST response for patients with measurable disease(Baseline, after every 4 courses, at the end of treatment, and then every 6 months)
- 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)
- Toxicity (adverse events considered to be at least possibly drug-related)(Baseline, day 1 of each course, and at the end of treatment)