Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy - Full Text View

Purpose

This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: Prednisone Drug: sunitinib Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Steroids

Drug Information available for: Prednisone Docetaxel Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall Survival (OS) [ Time Frame: Baseline up to 32 months ] [ Designated as safety issue: No ]
OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.

Secondary Outcome Measures:

Progression-Free Survival (PFS) [ Time Frame: Baseline, every 8 weeks up to 123 weeks ] [ Designated as safety issue: No ]
PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02
Percent of Participants With Objective Response (OR) [ Time Frame: Baseline, every 8 weeks up to 123 weeks ] [ Designated as safety issue: No ]
OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.
Duration of Response (DR) [ Time Frame: Baseline, every 8 weeks up to 123 weeks ] [ Designated as safety issue: No ]
Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response
Change From Baseline in Pain Severity [ Time Frame: Day 1 through Day 7 every 28 days (every cycle) up to 29 months ] [ Designated as safety issue: No ]
Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: Baseline, every 4 weeks up to 123 weeks ] [ Designated as safety issue: No ]
FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.
Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [ Time Frame: Baseline, every 4 weeks up to 123 weeks ] [ Designated as safety issue: No ]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction.

Enrollment:	873
Study Start Date:	July 2008
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Treatment Arm A - sunitinib + prednisone	Drug: Prednisone 5 mg BID, oral Other Name: Deltasone Drug: sunitinib 37.5 mg/day, oral, administered on a continuous daily dosing regimen Other Name: Sutent, SU011248
Placebo Comparator: B Treatment Arm B - placebo + prednisone	Drug: Placebo 37.5 mg/day, oral, administered on a continuous daily dosing regimen Drug: Prednisone 5 mg BID, oral Other Name: Deltasone

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate.
Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
Progressive disease based on PSA progression, RECIST, or positive bone scan.
ECOG 0 or 1.

Exclusion Criteria:

Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting.
Chemotherapy within 3 weeks.
Impending complications from bone metastases.
Ongoing urinary obstruction.
Cardiac dysfunction, QTc >470 msec.
CNS involvement.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676650

Show 205 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00676650 History of Changes
Other Study ID Numbers:	A6181120
Study First Received:	May 8, 2008
Results First Received:	December 20, 2012
Last Updated:	February 5, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Docetaxel-refractory mCRPC
Second-line treatment with sunitinib and prednisone

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Sunitinib
Glucocorticoids
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013

Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy (SUN 1120)