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Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: April 11, 2007   Last Updated: September 30, 2009   History of Changes
Sponsor: OHSU Knight Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00459810
  Purpose

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 Intervention Phase
Prostate Cancer
Biological: therapeutic estradiol
Drug: paclitaxel poliglumex
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
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

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • PSA response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Response rate [ Designated as safety issue: No ]
  • Time to PSA progression and measurable disease progression [ Designated as safety issue: No ]
  • Time to death [ Designated as safety issue: No ]
  • Correlation of levels of serum estradiol, serum cathepsin B, and bone turnover markers with PSA response [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2007
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459810

Locations
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
Investigators
Principal Investigator: Tomasz M. Beer, MD OHSU Knight Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: OHSU Knight Cancer Institute ( Tomasz M. Beer )
Study ID Numbers: CDR0000540438, OHSU-2656
Study First Received: April 11, 2007
Last Updated: September 30, 2009
ClinicalTrials.gov Identifier: NCT00459810     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Urogenital Neoplasms
Estradiol 17 beta-cypionate
Reproductive Control Agents
Hormones
Neoplasms by Site
Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate
Estrogens
Mitosis Modulators
Antimitotic Agents
Genital Diseases, Male
Estradiol
Pharmacologic Actions
Neoplasms
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010