Pazopanib as Second Line Therapy in Patients With Metastatic Prostate Cancer Refractory to Total Androgen Blockade

NCT00945477 | Terminated Phase 2 Results

• 1 other identifier: ILCC #1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 4

Brief Summary

A growing body of literature supports the role of angiogenesis in the development and spread of a variety of human cancers including prostate cancer.

• Vascular endothelial growth factor (VEGF) expression is low in normal prostate tissue, but markedly increased in tumor tissues, and has a positive association with tumor stage and grade
• Plasma VEGF levels are significantly elevated in patients with hormone refractory prostate cancer (HRPC) compared to those patients with localized disease and have been associated with disease progression in other cancer patient population.
• The Cancer and Leukemic Group-B demonstrated that VEGF levels correlate with survival. Pazopanib is a potent multi-target receptor tyrosine kinase inhibitor of vascular endothelial growth factor receptors.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate at 12 Weeks

  Response rate defined as 50% decrease in the Prostate Specific Antigen (PSA) level at week 12 compared to baseline

  12 weeks

Secondary Outcomes (1)

• Number Adverse Events, Grades 1-5 Using NCI-CTCAE v 3.0

  0-12 weeks

Study Arms (1)

Advanced prostate cancer, treatment, pazopanib

EXPERIMENTAL

Pazopanib

Drug: Pazopanib (GW786034)

Interventions

Pazopanib (GW786034) DRUG

Pazopanib 800 mg daily x 12 weeks

Also known as: Pazopanib monohydrochloride salt GW786034

Advanced prostate cancer, treatment, pazopanib

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of adenocarcinoma of the prostate histology, currently on total androgen blockage with a bicalutamide.
• Subjects must provide written informed consent prior to administration of pazopanib or the performance of any study-specific procedures or assessments, and must be willing to comply with treatment and follow up. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol. Note: It is not necessary that informed consent be obtained within the protocol-specified screening window.
• Received no prior second line hormone therapy or any chemotherapy. No prior bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic prostate cancer.
• Must have metastatic diagnosis, meaning disease beyond the prostate gland.
• A progressing PSA of ≥ 3, the PSA will be measured in ≥ 14 days.
• KPS of ≥ 70
• Age ≥ 18 years old
• Adequate organ system functions:
• Absolute neutrophil count (ANC) ≥ 1.5 X 109/L
• Hemoglobin ≥ 9 g/dL
• Platelets ≥ 100 X 109/L
• International normalized ratio (INR) ≤ 1.2 X upper limit of normal (ULN)
• Partial thromboplastin time (PTT) ≤ 1.2 X ULN
• Total bilirubin ≤ 1.5 X ULN
• AST and ALT ≤ 2.5 X ULN

You may not qualify if:

• Subjects meeting any of the following criteria must not be enrolled in the study:
• History of another malignancy.
• Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
• History or clinical evidence of central nervous system (CNS) metastases.
• Note: Subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:
• Are asymptomatic and,
• Have had no evidence of active CNS metastases for ≥ 6 months prior to enrollment and,
• Have no requirement for steroids or enzyme-inducing anticonvulsants (EIAC).
• Clinically significant gastrointestinal abnormalities including, but not limited to:
• Malabsorption syndrome,
• Major resection of the stomach or small bowel that could affect the absorption of study drug,
• Active peptic ulcer disease,
• Inflammatory bowel disease,
• Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation,
• History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.

Sponsors & Collaborators

• Illinois CancerCare, P.C.: lead

Study Sites (4)

Illinois CancerCare

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare

Pekin, Illinois, 61554, United States

Location

Illinois Cancer Care

Peoria, Illinois, 61615, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

pazopanib

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Because of slow enrollment, the study was terminated. The study planned enrollment of 34 subjects, 11 were enrolled.

Results Point of Contact

• Title: James Knost, M.D.
• Organization: Illinois CancerCare, P.C.

jknost@illinoiscancercare.com

309-243-3000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 22, 2009
• First Posted: July 24, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 18, 2013
• Results First Posted: November 18, 2013

Record last verified: 2013-10

Locations

US (4)