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Status:

TERMINATED

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

Lead Sponsor:

OHSU Knight Cancer Institute

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Prostate Cancer

Eligibility:

MALE

18-120 years

Phase:

PHASE2

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...

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 * Det...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2009

    Estimated Enrollment :

    21 Patients enrolled

    Trial Details

    Trial ID

    NCT00459810

    Start Date

    February 1 2007

    End Date

    July 1 2009

    Last Update

    April 28 2017

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, United States, 94115

    2

    OHSU Knight Cancer Institute

    Portland, Oregon, United States, 97239-3098