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

NCT01469338 | Terminated Phase 2 DMC

• 2 other identifiers: 4P-11-3NCI-2011-03266
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

• Prostate-Specific Antigen response

  Baseline, day 1 of each course, 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

Study Arms (1)

Supportive care (management of therapy complications)

EXPERIMENTAL

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; Drug: prednisone; Drug: octreotide pamoate; Other: questionnaire administration; Drug: octreotide acetate

Interventions

cabazitaxel DRUG

Given IV

Also known as: Jevtana, RPR-116258A, taxoid XRP6258, XRP6258

Supportive care (management of therapy complications)

prednisone DRUG

Given PO

Also known as: DeCortin, Deltra

Supportive care (management of therapy complications)

octreotide pamoate DRUG

Given IM

Also known as: OP LAR, Sandostatin pamoate, Sandostatin pamoate LAR, SMS 201-995 pa, SMS 201-995 pa LAR

Supportive care (management of therapy complications)

questionnaire administration OTHER

Ancillary studies

Supportive care (management of therapy complications)

octreotide acetate DRUG

Given SC

Also known as: Longastatin, Longastatina, Samilstin, SMS 201-995

Supportive care (management of therapy complications)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator
• Sanofi: collaborator

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Diarrhea; Prostatic Neoplasms

Interventions

cabazitaxel; XRP6258; Prednisone; Octreotide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jacek Pinski

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 10, 2011
• Study Start: July 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

US (1)