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Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00459810
Recruitment Status : Terminated
First Posted : April 13, 2007
Results First Posted : June 23, 2010
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Tom Beer, OHSU Knight Cancer Institute

Tracking Information
First Submitted Date  ICMJE April 11, 2007
First Posted Date  ICMJE April 13, 2007
Results First Submitted Date  ICMJE May 25, 2010
Results First Posted Date  ICMJE June 23, 2010
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE February 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2010)
Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50% [ Time Frame: While receiving study agents (on average, 3 months) ]
PSA response rate is defined at the number of patients who experienced a PSA decline of equal to or greater than 50%, confirmed by a second measurement at least 4 weeks later.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2007)
PSA Response Rate
Change History Complete list of historical versions of study NCT00459810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2010)
  • Measurable Disease Response Rate (Soft Tissue) [ Time Frame: While receiving study agents (on average, 3 months) ]
    Measurable disease response rate by RECIST criteria. Response is defined as at least a 30% decrease in the sum of the longest diameter in measurable lesions (larger than 10mm at baseline).
  • Time to Disease Progression [ Time Frame: At time of progression by PSA or RECIST criteria ]
    Time from Day 1 to Day of meeting criteria for PSA or Measurable Disease Progression
  • Time to Death [ Time Frame: Measured at Date of Death from any cause ]
    Defined as time from Day 1 of study regimen to Date of death from any cause.
  • Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response [ Time Frame: Measured after 4 cycles of combination therapy ]
    These correlative analyses were not completed. As there were no PSA responses, it was not possible to correlate serum estradiol, serum cathepsin B, or bone turnover markers with PSA response.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2007)
  • Toxicity
  • Response rate
  • Time to PSA progression and measurable disease progression
  • Time to Death
  • Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer
Official Title  ICMJE A Phase II Study of Paclitaxel Poliglumex (PPX) in Combination With Transdermal Estradiol for the Treatment of Androgen Independent Prostate Cancer After Docetaxel Chemotherapy
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estradiol may kill prostate cancer cells that no longer respond to hormone therapy. Giving paclitaxel poliglumex together with estradiol may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with estradiol works in treating patients with stage IV prostate cancer.

Detailed Description

OBJECTIVES:

Primary

  • Determine the PSA response rate in patients with androgen independent metastatic prostate cancer treated with paclitaxel poliglumex and transdermal estradiol.

Secondary

  • Determine the toxicity of this regimen in these patients.
  • Determine the response rate in patients treated with this regimen.
  • Determine the time to PSA progression and measurable disease progression in patients treated with this regimen.
  • Determine time to death from all causes in patients treated with this regimen.
  • Correlate levels of serum estradiol, serum cathepsin B, and bone turnover markers with PSA response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive transdermal estradiol continuously (patches changed every 7 days) until the PSA level rises. Patients whose PSA increases above baseline or PSA decreases < 10% after 4 weeks of estradiol therapy or whose serum PSA reduction is < 50% after 12 weeks of estradiol therapy also receive paclitaxel poliglumex therapy. These patients receive paclitaxel poliglumex IV over 10-20 minutes on day 1. Treatment with paclitaxel poliglumex repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: transdermal estradiol
    Transdermal estradiol given 0.2mg/day for duration of study.
  • Drug: paclitaxel poliglumex
    Paclitaxel poliglumex (PPX) is a macromolecular polymer-drug conjugate of paclitaxel. PPX was given every 28 days, at a dose of 150 mg/m2
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 25, 2010)
21
Original Enrollment  ICMJE
 (submitted: April 11, 2007)
50
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Stage IV disease

      • Radiographic evidence of regional or distant metastases
  • Evidence of disease progression (by PSA and/or imaging studies) despite standard hormonal therapy and after exposure to docetaxel-containing chemotherapy, as evidenced by any of the following:

    • Measurable or evaluable disease progression, defined as the appearance of new lesion(s) or unequivocal increase in previously existing lesions or masses
    • Disease progression by PSA*, defined by 1 of the following:

      • 3 consecutively rising PSA with the second PSA taken ≥ 1 week after the first PSA
      • 2 consecutively rising PSA with a fourth PSA > the second PSA NOTE: *The last required PSA must be after the required antiandrogen washout period for patients who have been on antiandrogen therapy
  • Must have received prior therapy with at least two 3-weekly doses or six weekly doses of docetaxel

    • Patients may have discontinued therapy due to progression, intolerance, completion of planned therapy, or other reasons
    • Prior treatment with combinations of docetaxel with estramustine phosphate sodium or noncytotoxic agents (biologic agents) allowed
  • Serum testosterone < 50 ng/dL (unless surgically castrate)

    • Patients must continue androgen deprivation with a luteinizing hormone-releasing hormone agonist if they have not undergone orchiectomy
  • No known or suspected brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN
  • No other active malignancy except adequately treated nonmelanoma skin cancer or other noninvasive or in situ neoplasm
  • No other significant active medical illness or infection that would preclude study compliance
  • No significant cardiovascular illness, including any of the following:

    • NYHA class III or IV congestive heart failure
    • Unstable angina
    • Myocardial infarction within the past 6 months
    • Acute deep venous thrombosis
    • Acute pulmonary embolism
  • No significant peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 6 weeks since prior antiandrogen therapy (4 weeks for flutamide)

    • No current evidence of an antiandrogen withdrawal response
  • More than 4 weeks since prior radiotherapy
  • More than 8 weeks since prior radiopharmaceutical therapy (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium)
  • No prior paclitaxel
  • No other concurrent cytotoxic agents
  • No other concurrent chemotherapy or biologic response modifiers
  • No concurrent supplements known or suspected to contain supplemental estrogens
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00459810
Other Study ID Numbers  ICMJE CDR0000540438
OHSU-2656 ( Other Identifier: OHSU IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tom Beer, OHSU Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Tomasz M. Beer, MD OHSU Knight Cancer Institute
PRS Account OHSU Knight Cancer Institute
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP