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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Southern California
Sponsor:
Collaborators:
Sanofi
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01469338
First received: November 1, 2011
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
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
Drug: cabazitaxel
Drug: prednisone
Drug: octreotide pamoate
Other: questionnaire administration
Drug: octreotide acetate
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Development of Grade 2 plus diarrhea [ Time Frame: Baseline through 21 days after the last administration of cabazitaxel ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-Free Survival [ Time Frame: At 1 month after completion of treatment, every 3 months until disease progression, and then every 6 months thereafter ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: At 1 month after completion of treatment, every 3 months until disease progression, and then every 6 months thereafter ] [ Designated as safety issue: No ]
  • RECIST response for patients with measurable disease [ Time Frame: Baseline, after every 4 courses, at the end of treatment, and then every 6 months ] [ Designated as safety issue: No ]
  • Prostate-Specific Antigen response [ Time Frame: Baseline, day 1 of each course, at the end of treatment, and then every 6 months ] [ Designated as safety issue: No ]
  • Pain palliation in patients with a baseline pain score greater or equal to 2 [ Time Frame: Baseline, day 1 of each 3 week course, at the end of treatment, and then every 6 months for up to 52 weeks ] [ Designated as safety issue: No ]
  • Toxicity (adverse events considered to be at least possibly drug-related) [ Time Frame: Baseline, day 1 of each course, and at the end of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: cabazitaxel
Given IV
Other Names:
  • Jevtana
  • RPR-116258A
  • taxoid XRP6258
  • XRP6258
Drug: prednisone
Given PO
Other Names:
  • DeCortin
  • Deltra
Drug: octreotide pamoate
Given IM
Other Names:
  • OP LAR
  • Sandostatin pamoate
  • Sandostatin pamoate LAR
  • SMS 201-995 pa
  • SMS 201-995 pa LAR
Other: questionnaire administration
Ancillary studies
Drug: octreotide acetate
Given SC
Other Names:
  • Longastatin
  • Longastatina
  • Samilstin
  • SMS 201-995

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469338

Locations
United States, California
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Kristy Massopust, R.N.    323-865-0843    massopust@med.usc.edu   
Principal Investigator: Jacek Pinski         
Sponsors and Collaborators
University of Southern California
Sanofi
Investigators
Principal Investigator: Jacek Pinski University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01469338     History of Changes
Other Study ID Numbers: 4P-11-3, NCI-2011-03266
Study First Received: November 1, 2011
Last Updated: September 9, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Octreotide
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014