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

Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00499694
Enrollment
31
Registered
2007-07-11
Start date
2007-10-31
Completion date
2012-11-30
Last updated
2018-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate

Brief summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as satraplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving satraplatin together with bevacizumab may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving satraplatin together with bevacizumab works in treating patients with metastatic prostate cancer previously treated with docetaxel.

Detailed description

OBJECTIVES: Primary * Determine the time to progression in patients with metastatic androgen-independent prostate cancer previously treated with docetaxel currently treated with satraplatin and bevacizumab. Secondary * Determine the toxicity of this regimen in these patients. * Assess the prostate-specific antigen (PSA) response rate in patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. * Assess changes in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline phosphatase (BSAP) in patients treated with this regimen. * Correlate urine NTX and serum BSAP levels with time to progression in patients treated with this regimen. OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral satraplatin on days 1-5. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 28-42 days. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Interventions

BIOLOGICALbevacizumab

10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

80 mg/m(2), Orally, Days 1-5, every 35 days

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria: * Metastatic disease * Objective progression or rising prostate-specific antigen (PSA) despite androgen-deprivation therapy and antiandrogen withdrawal * Patients with rising PSA must demonstrate a rising trend with 2 successive elevations at a minimum interval of 1 week * Minimum PSA of 5 ng/mL or new areas of bony metastases on bone scan required if no measurable disease * No minimum PSA for measurable disease * Must have received ≤ 1 prior docetaxel-based chemotherapy for metastatic disease * No known CNS disease or brain metastases * Testosterone \< 0.5 ng/mL (castrate level) * Concurrent luteinizing-hormone releasing-hormone agonist allowed to maintain castrate level PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Life expectancy ≥ 12 weeks * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8.0 g/dL * Bilirubin normal * Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 50 mL/min * Urine protein:creatinine ratio ≤ 1.0 OR proteinuria ≤ 2+ by urine dipstick OR ≤ 1 g protein/24-hour urine collection * Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment * No significant traumatic injury within the past 28 days * Adequately controlled hypertension (defined as systolic blood pressure \[BP\] ≤ 150 mm Hg and/or diastolic BP ≤ 100 mm Hg on antihypertensive medications) * No history of hypertensive crisis or hypertensive encephalopathy * No New York Heart Association class II-IV congestive heart failure * No myocardial infarction or unstable angina within the past 6 months * No stroke or transient ischemic attack within the past 6 months * No significant vascular disease (e.g., aortic aneurysm, aortic dissection) * No symptomatic peripheral vascular disease * No evidence of bleeding diathesis or coagulopathy * No prior malignancy except adequately treated skin cancer or any other cancer in complete remission for ≥ 2 years * Able to swallow and retain capsules * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No serious nonhealing wound, ulcer, or bone fracture * No known hypersensitivity to any component of bevacizumab * No history of allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab * No uncontrolled intercurrent illness, including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * No psychiatric illness or social situation that would preclude compliance with study requirements * No HIV positivity * No immune deficiency PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior flutamide * More than 6 weeks since prior bicalutamide or nilutamide * At least 4 weeks since prior radiotherapy * At least 2 weeks since prior minor surgery * More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device) * More than 28 days since prior major surgery or open biopsy (8 weeks if high-risk procedure such as liver resection, thoracotomy, or neurosurgery) * Concurrent low-dose aspirin (≤ 325 mg/day) allowed * Concurrent anticoagulants allowed if patient has been on therapy ≥ 4 weeks and has no acute thromboembolic activity * No concurrent major surgery * No concurrent aprepitant * No concurrent immunosuppressive therapy * No concurrent combination anti-retroviral therapy for HIV-positive patients * No other concurrent antitumor therapy (including radiotherapy) * No other concurrent investigational agents

Design outcomes

Primary

MeasureTime frameDescription
Time to ProgressionEvery 70 daysProgression 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.

Secondary

MeasureTime frameDescription
Toxicity, Presented as the Number of Participants With Adverse EventsDay 1 of every cycle (35 days) and Day 15 of every cycleToxicity was categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 3.0).
Percentage of Participants With Prostate-specific Antigen (PSA) ResponseDay 1 of every cycle (35 days) and Day 15 of every cycleProstate-specific antigen (PSA) response rate as measured by a 50% or better decrease in PSA levels
Overall SurvivalFollowed every 3 months after treatment is discontinuedOverall survival using the Kaplan-Meier method

Countries

United States

Participant flow

Participants by arm

ArmCount
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
31
Total31

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyPatient never received treatment.1

Baseline characteristics

CharacteristicBevacizumab and Satraplatin
Age, Continuous67.5 years
STANDARD_DEVIATION 8.5
Region of Enrollment
United States
31 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
31 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
21 / 30
serious
Total, serious adverse events
7 / 30

Outcome results

Primary

Time to Progression

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.

Time frame: Every 70 days

ArmMeasureValue (MEDIAN)
Bevacizumab and SatraplatinTime to Progression7.0 months
Secondary

Overall Survival

Overall survival using the Kaplan-Meier method

Time frame: Followed every 3 months after treatment is discontinued

ArmMeasureValue (MEDIAN)
Bevacizumab and SatraplatinOverall Survival11.2 months
Secondary

Percentage of Participants With Prostate-specific Antigen (PSA) Response

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

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

ArmMeasureValue (NUMBER)
Bevacizumab and SatraplatinPercentage of Participants With Prostate-specific Antigen (PSA) Response17 pct. of pts. with 50%+ decrease in PSA
Secondary

Toxicity, Presented as the Number of Participants With Adverse Events

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

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsNausea16 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsVomiting11 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsDiarrhea10 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsLeukopenia14 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsNeutropenia10 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsAnemia12 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsEdema3 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsDehydration8 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsHyperglycemia21 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsThrombocytopenia19 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsProteinuria18 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsHypertension4 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsFatigue19 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsHypokalemia5 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsHyponatremia5 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse Eventshypomagnesemia4 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsAST7 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsCreatinine1 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsConstipation5 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsBloating/Distention2 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsFever/Rigors1 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsDyspepsia6 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsWeight Loss7 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsAnorexia8 Participants
Bevacizumab and SatraplatinToxicity, Presented as the Number of Participants With Adverse EventsAllergic Reaction2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026