Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients

NCT00879619 | Terminated Phase 1 Results DMC

• 3 other identifiers: UCI 07-642008-6187NCI-2010-00216
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: 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. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel and prednisone together with sunitinib malate may kill more tumor cells. PURPOSE: This pilot phase I/II trial studies the side effects and best way to give docetaxel and prednisone together with sunitinib malate and to see how well it works in treating patients with prostate cancer that progressed after hormone therapy.

Conditions

Prostate Cancer; Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Prostate Specific Antigen (PSA) Response Rate

  Defined by \>= 30% decline in PSA from baseline for at least 3 months during study entry. Response rates will be expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.

  Baseline, every 3 weeks, at study termination, and then for 3 years

Secondary Outcomes (5)

• Rates of Tumor Response (ORR)

  Every 2 months

• Duration of Response (DR)

  Up to 3 years

• Time to Progression (TTP) by PSA Response and Disease Response

  Baseline, every 3 weeks, at study termination, and then for 3 years

• Survival

  At 2 and 3 years

• Qualitative and Quantitative Toxicity

  Every 3 weeks and at study termination

Study Arms (1)

Chemotherapy and enzyme inhibitor

EXPERIMENTAL

Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Drug: sunitinib malate; Drug: docetaxel; Drug: prednisone

Interventions

sunitinib malate DRUG

Given PO

Also known as: SU11248, sunitinib

Chemotherapy and enzyme inhibitor

docetaxel DRUG

Given IV

Also known as: TXT

Chemotherapy and enzyme inhibitor

prednisone DRUG

Given PO

Also known as: Delta(1)-Cortisone, deltacortisone, deltadehydrocortisone, metacortandracin, PRD, PRED

Chemotherapy and enzyme inhibitor

Eligibility Criteria

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

You may qualify if:

• Subjects must have a histological diagnosis of adenocarcinoma of the prostate
• Age ≥ 18
• Subjects must have metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy by one or more of the following (despite androgen deprivation and anti-androgen withdrawal when applicable) check all that apply.
• Subjects may have received prior surgery. However, at least 21 days must have elapsed since completion of surgery and Subject must have recovered from all side effects.
• Subjects must have adequate hepatic function as defined by:
• a serum bilirubin ≤1.5 x the institutional upper limit of normal (IULN),
• Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) ≤2.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy
• Subjects must have 2 pre-study PSA \> 2ng/ml at least 1 week apart within 28 days prior to start of therapy
• Subjects must have been surgically or medically castrated. If method of castration is luteinizing hormone-releasing hormone (LHRH) agonist (leuprolide or goserelin), then the Subject should be willing to continue the use of LHRH agonists. Castration using LHRH agonist should not be interrupted and subjects who have stopped treatment should be willing to restart.
• Subjects must not take vitamins, herbs, or micronutrient supplement within 28 days prior to start of therapy.
• Prior external beam radiation therapy (to less than 30% of the bone marrow only) is allowed. This includes prior use of samarium, but subjects can not have received prior strontium. At least 28 days must have elapsed since the completion of radiation therapy and the Subject must have recovered from side effects. Soft tissue disease which has been radiated in the prior 2 months is not assessable as measurable disease.
• Subjects with a history of myocardial infarction are not eligible. Subjects must have a baseline EKG to rule out underlying cardiac disease within 42 days prior to registration. Subjects with a history of cardiac disease, specifically congestive heart failure (CHF) are ineligible unless their disease is well-controlled. Subjects with history of cardiovascular accident (CVA) or atrial fibrillation are ineligible.
• Subjects with a history of brain metastases or who currently have treated or untreated brain metastases are not eligible. Subjects with clinical evidence of brain metastases must have a brain CT or MRI negative for metastatic disease within 56 days prior to registration.
• \*Liver function tests should be evaluated prior to each treatment.
• Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

You may not qualify if:

• Subjects must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to start of therapy and must have recovered from toxicities of prior therapy to grade 1 or less with the exception of alopecia.
• Subjects may not have ongoing problems with bowel obstruction or short bowel syndrome characterized by grade 2 or greater diarrhea or malabsorptive disorders.
• Men of child bearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
• Subjects with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 will be excluded
• Subjects should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol.
• Subjects should not have any medical life-threatening complications of their malignancies
• Subjects should not have a known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV).
• Subjects should not have current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
• Baseline blood pressure of \< or equal to 150/100 mmHg. Subjects with a blood pressure reading above this level should be initiated on anti-hypertensive therapy and may be considered for protocol treatment when their blood pressure is adequately controlled.
• Subjects with New York Heart Association (NYHA) Grade II or greater congestive heart failure are not eligible. Subjects must have a baseline multiple gated acquisition scan (MUGA) or Echocardiogram with a calculated ejection fraction \> or equal to 50%.
• Subjects with clinically significant peripheral vascular disease are not eligible.
• Subjects with evidence of bleeding diathesis or coagulopathy are not eligible.
• Subjects with central nervous system or brain metastases are not eligible.
• Subjects who had major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study are not eligible.
• Subjects with minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0 are not eligible.

Sponsors & Collaborators

• John P. Fruehauf: lead
• Sanofi: collaborator

Study Sites (1)

Chao Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Related Links

• (UCi Clinical Trials webpage

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sunitinib; Docetaxel; Prednisone; prednylidene

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)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The study was terminated due to slow accrual. Zero subjects were analyzed.

Results Point of Contact

• Title: Nicole Macaranas, Clinical Research Specialist
• Organization: University of California, Irvine

nicole.macaranas@uci.edu

714-456-6550

Study Officials

• John P Fruehauf, MD, PhD

  Chao Family Comprehensive Cancer Center

  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: SPONSOR INVESTIGATOR
• PI Title: Dr. John P. Fruehauf

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 10, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 1, 2017
• Results First Posted: June 6, 2013

Record last verified: 2013-04

Locations

US (1)