Trial Outcomes & Findings for Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients (NCT NCT00879619)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

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

Results posted on

2017-02-01

Participant Flow

Study start date: July 2009 Primary completion date: October 2011 Study completion date: November 2011

Participant milestones

Participant milestones
Measure	Chemotherapy and Enzyme Inhibitor Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO once daily (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. prednisone : Given PO docetaxel : Given IV sunitinib malate : Given PO
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy and Enzyme Inhibitor n=4 Participants 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. prednisone : Given PO docetaxel : Given IV sunitinib malate : Given PO
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Gender Female	0 Participants n=5 Participants
Gender Male	4 Participants n=5 Participants

PRIMARY outcome

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 2 months

Response rates will be expressed with two-sided exact binomial confidence intervals. The difference of response rates between different pre-treatment pathological stages or Gleason scores will also be examined by Fisher's exact test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Response rates will be expressed with two-sided exact binomial confidence intervals.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Defined as an absolute increase in PSA of at least 2 ng/ml. For subjects with measurable disease, Response Evaluation Criteria In Solid Tumors (RECIST) criteria will be used. 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 2 and 3 years

Quantitative Kaplan-Meyer estimates of progression-free survival and overall survival will be determined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 3 weeks and at study termination

Severity will be categorized by toxicity grade according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Categorical analysis of toxicities will be performed.

Outcome measures

Outcome data not reported

Adverse Events

Chemotherapy and Enzyme Inhibitor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chemotherapy and Enzyme Inhibitor n=4 participants at risk 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. prednisone : Given PO docetaxel : Given IV sunitinib malate : Given PO
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Number of events 1 • At first study drug treatment during the initial treatment period until 28 days after the last administration of study drug.

Additional Information

Nicole Macaranas, Clinical Research Specialist

University of California, Irvine

Phone: 714-456-6550

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place