Trial Outcomes & Findings for Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel (NCT NCT00499694)

Last Updated: 2018-06-12

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. TTP is measured using Kaplan-Meier product-limit.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

Every 70 days

Results posted on

2018-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Bevacizumab and Satraplatin Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Bevacizumab and Satraplatin Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days
Overall Study Patient never received treatment.	1

Baseline Characteristics

Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab and Satraplatin n=31 Participants Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days
Age, Continuous	67.5 years STANDARD_DEVIATION 8.5 • n=39 Participants
Sex: Female, Male Female	0 Participants n=39 Participants
Sex: Female, Male Male	31 Participants n=39 Participants
Region of Enrollment United States	31 participants n=39 Participants

PRIMARY outcome

Timeframe: Every 70 days

Outcome measures

Outcome measures
Measure	Bevacizumab and Satraplatin n=31 Participants Bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) Bevacizumab: 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days
Time to Progression	7.0 months Interval 4.7 to 8.5

SECONDARY outcome

Timeframe: Day 1 of every cycle (35 days) and Day 15 of every cycle

Toxicity was categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 3.0).

Outcome measures

Outcome measures
Measure	Bevacizumab and Satraplatin n=31 Participants Bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) Bevacizumab: 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days
Toxicity, Presented as the Number of Participants With Adverse Events Nausea	16 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Vomiting	11 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Diarrhea	10 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Leukopenia	14 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Neutropenia	10 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Anemia	12 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Edema	3 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Dehydration	8 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Hyperglycemia	21 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Thrombocytopenia	19 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Proteinuria	18 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Hypertension	4 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Fatigue	19 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Hypokalemia	5 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Hyponatremia	5 Participants
Toxicity, Presented as the Number of Participants With Adverse Events hypomagnesemia	4 Participants
Toxicity, Presented as the Number of Participants With Adverse Events AST	7 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Creatinine	1 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Constipation	5 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Bloating/Distention	2 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Fever/Rigors	1 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Dyspepsia	6 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Weight Loss	7 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Anorexia	8 Participants
Toxicity, Presented as the Number of Participants With Adverse Events Allergic Reaction	2 Participants

SECONDARY outcome

Timeframe: Day 1 of every cycle (35 days) and Day 15 of every cycle

Prostate-specific antigen (PSA) response rate as measured by a 50% or better decrease in PSA levels

Outcome measures

Outcome measures
Measure	Bevacizumab and Satraplatin n=30 Participants Bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) Bevacizumab: 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days
Percentage of Participants With Prostate-specific Antigen (PSA) Response	17 pct. of pts. with 50%+ decrease in PSA Interval 8.0 to 30.0

SECONDARY outcome

Timeframe: Followed every 3 months after treatment is discontinued

Overall survival using the Kaplan-Meier method

Outcome measures

Outcome measures
Measure	Bevacizumab and Satraplatin n=31 Participants Bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) Bevacizumab: 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days
Overall Survival	11.2 months Interval 9.1 to 16.4

Adverse Events

Bevacizumab and Satraplatin

Serious events: 7 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab and Satraplatin n=30 participants at risk Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days
Gastrointestinal disorders Diarrhea	6.7% 2/30 • Number of events 2
Investigations Leukeopenia	6.7% 2/30 • Number of events 2
Blood and lymphatic system disorders Neutropenia	13.3% 4/30 • Number of events 4
Blood and lymphatic system disorders Anemia	23.3% 7/30 • Number of events 7
Metabolism and nutrition disorders Dehydration	3.3% 1/30 • Number of events 1
Metabolism and nutrition disorders Hyperglycemia	6.7% 2/30 • Number of events 2
Blood and lymphatic system disorders Thrombocytopenia	10.0% 3/30 • Number of events 3
Vascular disorders Hypertension	10.0% 3/30 • Number of events 3
Gastrointestinal disorders Fatigue	3.3% 1/30 • Number of events 1
Vascular disorders Thrombosis_PE	6.7% 2/30 • Number of events 2
Metabolism and nutrition disorders Hyponatremia	3.3% 1/30 • Number of events 1
Metabolism and nutrition disorders Hypokalemia	3.3% 1/30 • Number of events 1
Metabolism and nutrition disorders Hypophosphatemia	6.7% 2/30 • Number of events 2
Gastrointestinal disorders Bloating Distention	3.3% 1/30 • Number of events 1
Immune system disorders Allergic Reaction	3.3% 1/30 • Number of events 1

Other adverse events

Other adverse events
Measure	Bevacizumab and Satraplatin n=30 participants at risk Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days
Gastrointestinal disorders Nausea	53.3% 16/30 • Number of events 16
Gastrointestinal disorders Vomiting	36.7% 11/30 • Number of events 11
Gastrointestinal disorders Diarrhea	33.3% 10/30 • Number of events 10
Blood and lymphatic system disorders Leukopenia	46.7% 14/30 • Number of events 14
Blood and lymphatic system disorders Neutropenia	33.3% 10/30 • Number of events 10
Blood and lymphatic system disorders Anemia	40.0% 12/30 • Number of events 12
General disorders Edema	10.0% 3/30 • Number of events 3
Metabolism and nutrition disorders Dehydration	26.7% 8/30 • Number of events 8
Metabolism and nutrition disorders Hyperglycemia	70.0% 21/30 • Number of events 21
Blood and lymphatic system disorders Thrombocytopenia	63.3% 19/30 • Number of events 19
Renal and urinary disorders Proteinuria	60.0% 18/30 • Number of events 18
Vascular disorders Hypotension	13.3% 4/30 • Number of events 4
General disorders Fatigue	63.3% 19/30 • Number of events 19
Metabolism and nutrition disorders Hypokalemia	16.7% 5/30 • Number of events 5
Metabolism and nutrition disorders Hyponatremia	16.7% 5/30 • Number of events 5
Metabolism and nutrition disorders Hypomagnesemia	13.3% 4/30 • Number of events 4
Investigations AST	23.3% 7/30 • Number of events 7
Investigations Creatinine	23.3% 7/30 • Number of events 7
Gastrointestinal disorders Constipation	16.7% 5/30 • Number of events 5
Gastrointestinal disorders Bloating Distention	6.7% 2/30 • Number of events 2
Gastrointestinal disorders Dyspepsia	20.0% 6/30 • Number of events 6
Investigations Weight loss	23.3% 7/30 • Number of events 7
Metabolism and nutrition disorders Anorexia	26.7% 8/30 • Number of events 8
Immune system disorders Allergic Reaction	6.7% 2/30 • Number of events 2

Additional Information

Ulka Vaishampayan, M.D.

Barbara Ann Karmanos Cancer Institute

Phone: (313) 576-8718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place