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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01469338
• Other study ID #: 4P-11-3
• Secondary ID: NCI-2011-03266
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 2011
• Last updated: November 21, 2014
• Start date: July 2012
• Est. completion date: November 2014

Study information

• 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

Clinical Trial 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

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 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).

III. Prostate-specific antigen (PSA) response rate.

IV. Objective response rate.

V. Pain response.

VI. Toxicity.

OUTLINE:

Patients receive cabazitaxel as intravenous (IV) infusion over 1 hour on day 1, prednisone by mouth (PO) every day (QD), and octreotide pamoate given as intramuscular (IM) injection on day 1. Patients also receive octreotide acetate as a subcutaneous (SC) injection three times a day (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. After completion of study treatment, patients are followed up at 1 month, every 3 months until disease progression, and then every 6 months thereafter.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diarrhea
• Hormone-resistant Prostate Cancer
• Prostatic Neoplasms
• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer
• Stage IV Prostate Cancer

Intervention

Drug:
• cabazitaxel
Given IV
• prednisone
Given PO
• octreotide pamoate
Given IM

Other:
• questionnaire administration
Ancillary studies

Drug:
• octreotide acetate
Given SC

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI), Sanofi

Country where clinical trial is conducted

United States, 

Outcome

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