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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer

NCTNCT00658697 (opens ClinicalTrials.gov in a new tab)Other id08-004
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
42 participants (actual)
Sponsor
Dana-Farber Cancer Institute · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jun 2008
Primary completion
Sept 2014
Completion
Jun 2015
First posted
15 Apr 2008 (estimated)
Last update posted
25 May 2017
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082010201220142016
  1. Ph 2

    Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer

    NCT00658697

    Jun 2008 to Jun 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

In this research study, we aim to evaluate the feasibility, toxicity and efficacy of early multimodality systemic therapy (a combination of docetaxe, bevacizumab, and androgen deprivation therapy(ADT) in men with biochemical recurrence (BCR) or who have a rising Prostate Specific Antigen (PSA) after treatment of their prostate cancer with surgery or radiation)

Interventions

  • DocetaxelDrug
  • BevacizumabDrug
  • ADTDrug
  • BicalutamideDrug

Arms1

  • Experimental

    Docetaxel, Bevacizumab, and ADT

    Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT)

    Time frame · participants were followed for the duration of the study, an average of 2 years

    Registry description

    For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA \> 0.2 ng/mL. For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA \>2.0 ng/mL. Any new site of metastatic disease on imagining would be considered progression regardless of PSA value Clinical assessments (Vitals, Physical Exam, Performance Status, PSA and testosterone) were performed every 3 months starting at completion of hormone therapy until PSA progression.

Secondary outcomes(4)

  1. Proportion of Patients With PSA Responses at One Year After the Completion of ADT

    Time frame · 1 year + 3 month off last ADT injection

    Registry description

    The PSA response was defined using two cut-offs: PSA \<0.2 ng/mL or PSA \<0.01 ng/mL at the one year after completion of ADT.

  2. Time to PSA Progression (TTP)

    Time frame · participants were followed for the duration of the study, an average of 2 years

    Registry description

    For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA \> 0.2 ng/mL. For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA \> 2.0 ng/mL. Any new site of metastatic disease on imagining would be considered progression regardless of PSA value

  3. Testosterone Recovery

    Time frame · 2 years

    Registry description

    Testosterone recovery was defined as \>100 or within DFCI institute normal range (240-950) at one year after the completion of ADT

  4. Toxicity

    Time frame · Assessed each cycle throughout treatment form time of first dose to 30 days post-treatment, up to 2 years

    Registry description

    Treatment related adverse events were graded based on CTCAE v. 3.0.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· participants were followed for the duration of the study, an average of 2 years

Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT)

GroupValue (percentage of participants with data)
Docetaxel, Bevacizumab, and ADT98
Secondary and other outcome results(4)
Secondary outcomeNumber· 1 year + 3 month off last ADT injection

Proportion of Patients With PSA Responses at One Year After the Completion of ADT

GroupValue (percentage of participants with data)
Docetaxel, Bevacizumab, and ADT44
Secondary outcomeMedian· participants were followed for the duration of the study, an average of 2 years

Time to PSA Progression (TTP)

GroupValue (months)
Docetaxel, Bevacizumab, and ADT27.5
Secondary outcomeNumber· 2 years

Testosterone Recovery

GroupValue (percentage of participants with data)
Docetaxel, Bevacizumab, and ADT83
Secondary outcomeNumber· Assessed each cycle throughout treatment form time of first dose to 30 days post-treatment, up to 2 years

Toxicity

GroupValue (participants)
Docetaxel, Bevacizumab, and ADT16

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Docetaxel, Bevacizumab, and ADTDocetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) Docetaxel Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed–21 / 4141 / 41

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 18 years of age or older * History of biopsy documented prostate cancer (any Gleason score) * Past treatment with prostatectomy with our without salvage prostate/pelvic radiation or primary radiation * If past prostatectomy, pathologic stage no greater than T1-3, N1, M0 * PSA recurrence with PSAdt 8 months or less. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be 2.0ng/ml or greater * No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis on CXR * Prior ADT allowed if less than 6 months and testosterone recovered to within 50 units of normal range * ECOG Performance status of 0-1 * Absolute neutrophil count of 1,500 mm3 or greater * Platelet Count 100,000 mm3 or greater * Total bilirubin within normal limits * HG 8gm/dl or greater * Testosterone within 50 units of normal range * No history of bleeding or thromboses within the last 12 months that required medical intervention Exclusion Criteria: * History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer * Medical condition requiring concomitant corticosteroids * Active infection * Prior chemotherapy * Neuropathy requiring medical therapy * Documented local recurrence or metastatic prostate cancer * Inability to comply with study and/or follow-up procedures * Life expectancy of less than 2 years * Current, recent (within 4 weeks of first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study * Inadequately controlled hypertension * Any prior history of hypertensive crisis or hypertensive encephalopathy * NYHA Grade II or greater congestive heart failure * History of myocardial infarction or unstable angina within 12 months prior to study enrollment * History of stroke or transient ischemic attack at any time * Known CNS disease * Significant vascular disease * Symptomatic peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrollment * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment * Serious, non-healing wound, ulcer, or bone fracture * Proteinuria at screening * Known hypersensitivity to any component of Avastin

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