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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00459810
Recruitment Status : Terminated
First Posted : April 13, 2007
Results First Posted : June 23, 2010
Last Update Posted : April 28, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Tom Beer, OHSU Knight Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: transdermal estradiol Drug: paclitaxel poliglumex Phase 2

Detailed Description:



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


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Paclitaxel Poliglumex (PPX) in Combination With Transdermal Estradiol for the Treatment of Androgen Independent Prostate Cancer After Docetaxel Chemotherapy
Study Start Date : February 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Intervention Details:
  • 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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.

  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00459810

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United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
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Principal Investigator: Tomasz M. Beer, MD OHSU Knight Cancer Institute

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Responsible Party: Tom Beer, Principal Investigator, OHSU Knight Cancer Institute Identifier: NCT00459810    
Other Study ID Numbers: CDR0000540438
OHSU-2656 ( Other Identifier: OHSU IRB )
First Posted: April 13, 2007    Key Record Dates
Results First Posted: June 23, 2010
Last Update Posted: April 28, 2017
Last Verified: April 2017
Keywords provided by Tom Beer, OHSU Knight Cancer Institute:
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Albumin-Bound Paclitaxel
Paclitaxel poliglumex
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female