Cediranib Maleate With or Without Dasatinib in Patients With Hormone-Resistant Prostate Cancer Resistant to Treatment With Docetaxel
This randomized phase II trial is studying the side effects and how well giving cediranib maleate together with or without dasatinib works in treating patients with hormone-resistant prostate cancer resistant to treatment with docetaxel. Cediranib maleate and dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. It is not yet known whether giving cediranib maleate together with dasatinib or alone is an effective treatment for prostate cancer
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Drug: cediranib maleate
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Randomized Study of Cediranib (AZD2171) Alone Compared With the Combination of Cediranib (AZD2171) Plus BMS-354825 (Dasatinib, Sprycel) in Docetaxel Resistant, Castration Resistant Prostate Cancer|
- Progression-free survival rate as per the Prostate Cancer Clinical Trials Working Group (PCWG2) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Compared between the two arms using Z test.
- Incidence of toxicities graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.0 [ Time Frame: Up to 30 days after last dose of study drugs ] [ Designated as safety issue: Yes ]
- Symptom assessment using FACT-P questionnaire and PPI scale [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: cediranib maleate
Other Names:Drug: dasatinib
Experimental: Arm II
Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: cediranib maleate
I. To determine the progression-free survival of patients with docetaxel-resistant and castration-resistant prostate cancer treated with cediranib maleate with versus without dasatinib.
I. To confirm the safety and tolerability of cediranib maleate with versus without dasatinib in these patients.
II. To calculate objective response rates of cediranib maleate with versus without dasatinib, according to RECIST criteria, in patients with measurable disease at baseline.
III. To perform symptom assessment using the FACT-P questionnaire and the Present Pain Intensity (PPI) scale from the McGill-Melzack questionnaire.
IV. To explore bone resorption markers (e.g., c-telopeptide and bone alkaline phosphatase), and to correlate these biomarkers with clinical outcome.
OUTLINE: This is a multicenter study. Patients are stratified according to the presence of soft tissue (visceral or nodal) vs bone-only disease. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients may undergo blood sample collection for bone resorption marker studies. Patients' archived tumor specimens are also analyzed for c-Src protein expression and activity. Patients complete the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaires and the Present Pain Intensity (PPI) scale at baseline and periodically during study.
After completion of study therapy, patients are followed up for 4 weeks.
|United States, Illinois|
|Peoria, Illinois, United States, 61615|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 60702|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard|
|Fort Wayne, Indiana, United States, 46845|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287-8936|
|Canada, British Columbia|
|BCCA-Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Sebastien Hotte||University Health Network-Princess Margaret Hospital|