Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

NCT01468532 | Completed Phase 1 Results

• 2 other identifiers: 2011-031NCI-2011-03216
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I/II trial studies the side effects and best dose of pasireotide and to see how well it works when given together with docetaxel and prednisone in treating patients with metastatic hormone-resistant prostate cancer. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pasireotide may inhibit the secretion of hormones. Giving pasireotide together with docetaxel and prednisone may kill more tumor cells.

Conditions

Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Pasireotide in Combination With Docetaxel and Prednisone by the Occurrence of Adverse Events and the Associated Grade Per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

  To identify the maximum tolerated dose (MTD) of pasireotide, The occurrence rate of binary endpoints (eg, specific types of toxicity at a certain dose level and severity grade, response, etc) will be described by point estimates and exact 90% confidence intervals (CIs) for proportions using Wilson's method.

  Up to day 57

Secondary Outcomes (8)

• The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0

  On days 1, 8, 15, 22, 29, 36 43, 50 and 57

• Measurements of Tumor Using Response Evaluation Criteria In Solid Tumors (RECIST) Criteria Before and After Treatment With the Combination of Pasireotide in Combination With Docetaxel

  Every 12 weeks for the first 36 weeks and then every 16 weeks thereafter up to 100 weeks

• Percentage Prostate-specific Antigen (PSA) Change Noted

  On days 1, 22, 43

• Time to Progression (TTP)

  Every 3 months for the first 9 months on study then every 4 months after the first 9 months on study, up to 2 years

• Overall Survival (OS)

  Every 3 months for the first 9 months on study then every 4 months after the first 9 months on study

Study Arms (1)

Treatment (chemotherapy, receptor agonist)

EXPERIMENTAL

Patients receive pasireotide IM, 40 mg on day 1, docetaxel 75mg/m2 IV over 1 hour, and prednisone 5mg PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: docetaxel; Drug: pasireotide; Drug: prednisone

Interventions

docetaxel DRUG

Given IV

Also known as: RP 56976, Taxotere, TXT

Treatment (chemotherapy, receptor agonist)

pasireotide DRUG

Given IM

Also known as: SOM230

Treatment (chemotherapy, receptor agonist)

prednisone DRUG

Given PO

Also known as: DeCortin, Deltra

Treatment (chemotherapy, receptor agonist)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed prostate adenocarcinoma with metastasis, and objective progression or rising PSA despite androgen deprivation therapy and antiandrogen withdrawal when applicable; patients with rising PSA must demonstrate a rising trend with 2 successive elevations at a minimum interval of 1 week; a minimum PSA of 5 ng/ml or new areas of bony metastases on bone scan are required for patients with no measurable disease; no minimum PSA requirement for patients with measurable disease
• Patient must not have received any prior chemotherapy for metastatic disease; all patients must be documented to be castrate with a testosterone level \< 0.5 ng/ml; luteinizing hormone-releasing hormone (LHRH) agonist therapy must be continued, if required to maintain castrate levels of testosterone; patients must be off antiandrogens for a minimum of 4 weeks for flutamide and 6 weeks for bicalutamide or nilutamide
• Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy)
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Life expectancy 12 weeks or more
• Absolute neutrophil (ANC) \>= 1.5 x 10\^9/L
• Platelets \>= 100 x 10\^9/L
• Hemoglobin (Hgb) \> 9 g/dL
• Serum bilirubin =\< 2 x upper limit of normal (ULN)
• Serum transaminases activity =\< 3 x ULN, with the exception of serum transaminases (\< 5 x ULN) if the patient has liver metastases
• Serum creatinine =\< 1.5 x ULN
• Fasting serum cholesterol =\< 300 mg/dL OR =\< 7.75 mmol/L AND fasting triglycerides =\< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
• Patients must be advised of the importance of using effective birth control measures during the course of the study
• Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information

You may not qualify if:

• Prior treatment with any cytotoxic chemotherapy, radiation, immunotherapy, or any investigational drug within the preceding 4 weeks
• Patients who have undergone major surgery within 4 weeks prior to study enrollment
• Chronic treatment with immunosuppressive agents except steroids
• Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry
• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
• Patients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years
• Patients with uncontrolled diabetes mellitus, which is defined as a hemoglobin A1C \> 8% on therapy or \> 7% without therapy, or a fasting plasma glucose \> 1.5 ULN; Note: at the principle investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted
• Patients with symptomatic cholelithiasis
• Patients who have congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
• Patients with baseline QTc \> or = 470 msec
• History of syncope or family history of idiopathic sudden death
• Sustained or clinically significant cardiac arrhythmias
• Patients with risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block
• Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes or Parkinson's disease), human immunodeficiency virus (HIV), cirrhosis, uncontrolled hypothyroidism or cardiac failure
• Concomitant medication(s) known to prolong the QT interval

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; pasireotide; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Ulka N. Vaishampayan
• Organization: Barbara Ann Karmanos Cancer Institute

vaishamu@karmanos.org

313-576-8718

Study Officials

• Ulka Vaishampayan

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: November 9, 2011
• Study Start: October 1, 2011
• Primary Completion: July 20, 2017
• Study Completion: July 20, 2017
• Last Updated: March 25, 2021
• Results First Posted: March 25, 2021

Record last verified: 2021-03

Locations

US (1)