Pazopanib, Docetaxel, Prednisone Prostate
Phase I Study of Docetaxel, Prednisone and Pazopanib in Men With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) and Poor-Risk Factors
3 other identifiers
interventional
36
1 country
2
Brief Summary
The primary purpose is to define the safety and tolerability of docetaxel/prednisone in combination with pazopanib (DPP) in men with metastatic Castration Resistant Prostate Cancer (mCRPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 prostate-cancer
Started Jun 2011
Typical duration for phase_1 prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 12, 2011
CompletedFirst Posted
Study publicly available on registry
June 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJune 6, 2018
June 1, 2018
4.1 years
June 12, 2011
June 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and Percent of Participants with Adverse Events as a Measure of Safety and Tolerability
The primary objective for the phase I study is to assess the safety and tolerability of pazopanib, docetaxel, and prednisone given in combination in patients with metastatic castration resistant prostate cancer.
15 months
Secondary Outcomes (2)
Establish the maximum tolerated dose
15 months
Establish the optimal dosing schedule
15 months
Study Arms (2)
Dose Level "Xa"
EXPERIMENTALonce daily pazopanib for Days 1-21 in combination with docetaxel given IV on Day 1 and prednisone daily. Pegfilgrastim (Neulasta) every 21 days on Day 2, 3 or 4 of each cycle.
Dose Level "Xb"
EXPERIMENTALonce daily oral administration of pazopanib for Days 3-19 in combination with docetaxel given intravenous administration on Day 1 and prednisone daily. Pegfilgrastim (Neulasta) every 21 days on Day 2, 3 or 4 of each cycle.
Interventions
Dose Level "Xa" - daily administration of pazopanib on days 1 through 21 starting at 400mg with a maximum dose of 1000mg.
Docetaxel given IV on Day 1 starting dose 60mg/m2 increase to 75mg/m2
Eligibility Criteria
You may qualify if:
- Histologically confirmed carcinoma of the prostate. Histologic evidence may be confirmed through local or metastatic biopsy review. Non-adenocarcinomas are permitted.
- Radiographic evidence of metastatic disease; non-evaluable, bone only metastasis is permitted.
- Evidence of disease progression despite castrate levels of testosterone (\<50 ng/dl).
- At the time of screening, at least 2 weeks since prior palliative radiation therapy and 4 weeks from major surgery, and resolution of all toxic effects of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE); version 4.0 Grade \< 1.
- Age \>18 years
- Adequate laboratory parameters
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Life expectancy greater than 3 months
- Written, signed and dated Institutional Review Board (IRB) approved informed consent form.
You may not qualify if:
- History of or active central nervous system metastases
- The use of immunologic, biologic, or hormonal therapies within 2 weeks of study entry.
- Major surgery, open biopsy, traumatic injury within 4 weeks of the screening visit
- Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.
- Previous treatment with docetaxel, including in the neo-adjuvant or adjuvant setting
- Presence of non-healing wound or ulcer
- Grade 3 or greater hemorrhage within the past month.
- Uncontrolled hypertension
- Anticoagulation with warfarin (therapeutic doses of warfarin for catheter patency are permitted up to 2 mg/day). Low molecular weight heparin is permitted.
- Diabetes mellitus with glycosylated hemoglobin A1c (HbgA1c) \> 8% despite therapy
- Subjects with active autoimmune disorder(s) being treated with systemic immunosuppressive agents within 4 weeks prior to the screening visit.
- Active infection(s), active antimicrobial therapy or serious intercurrent illness.
- Does not agree to use medically acceptable contraceptive methods while on study and for 3 months after the last dose of pazopanib.
- Any other major medical or psychiatric illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study, including inability to absorb oral medications.
- Known hypersensitivity to any of the components in the docetaxel infusion or other medical reasons for not being able to receive adequate premedication (for example, antihistamine or anti-inflammatory agents).
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daniel George, MDlead
- GlaxoSmithKlinecollaborator
Study Sites (2)
The University of Chicago
Chicago, Illinois, 60637, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel J George, MD
Duke Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
June 12, 2011
First Posted
June 30, 2011
Study Start
June 1, 2011
Primary Completion
July 1, 2015
Study Completion
February 1, 2016
Last Updated
June 6, 2018
Record last verified: 2018-06