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Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
This study has been completed.
Study NCT00005627   Information provided by National Cancer Institute (NCI)
First Received: May 2, 2000   Last Updated: July 23, 2008   History of Changes

May 2, 2000
July 23, 2008
March 1999
 
 
 
Complete list of historical versions of study NCT00005627 on ClinicalTrials.gov Archive Site
 
 
 
Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase I Study of Estramustine, Taxotere and Carboplatin (ETP) in Patients With Horomone Refractory Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of estramustine, docetaxel, and carboplatin in treating patients who have prostate cancer that has not responded to hormonal therapy.

OBJECTIVES:

  • Determine the maximum tolerated dose of weekly docetaxel when combined with carboplatin and estramustine in patients with hormone refractory prostate cancer.
  • Determine the safety and efficacy of this regimen in this patient population.

OUTLINE: This is a dose escalation study of docetaxel.

Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2 of weeks 1-3. Patients also receive carboplatin IV over 1 hour on day 2 of week 1 only. Treatment continues every 28 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 12 months.

Phase I
Interventional
Treatment
Prostate Cancer
  • Drug: carboplatin
  • Drug: docetaxel
  • Drug: estramustine phosphate sodium
 
Oh WK, Hagmann E, Manola J, George DJ, Gilligan TD, Jacobson JO, Smith MR, Kaufman DS, Kantoff PW. A phase I study of estramustine, weekly docetaxel, and carboplatin chemotherapy in patients with hormone-refractory prostate cancer. Clin Cancer Res. 2005 Jan 1;11(1):284-9.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Disease progression following androgen ablation therapy (hormonal or surgical) by either:

    • Increase in the product of bidimensional diameters of 1 or more radiographically documented sites of measurable disease OR
    • Two consecutive increases in PSA documented over a previous reference value

      • First increase in PSA should occur a minimum of 1 week from the reference value and be confirmed
      • First PSA value is less than the previous value, then patient is eligible provided next PSA is greater than the second PSA
  • Testosterone levels documented in the castrate range (i.e., less than 30 ng/mL)

PATIENT CHARACTERISTICS:

Age:

  • 18 to 85

Performance status:

  • CALGB 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin normal
  • SGOT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase normal OR
  • Alkaline phosphatase no greater than 4 times ULN if SGOT normal OR
  • SGOT no greater than 1.5 times ULN and alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No myocardial infarction within past year
  • No significant change in anginal pattern within past 6 months
  • No New York Heart Association class II-IV heart disease
  • No deep venous thrombosis within past year

Other:

  • No significant peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior chemotherapy allowed except taxanes or platinum derivatives

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior antiandrogens

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • See Disease Characteristics
Male
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005627
 
CDR0000067775, DFCI-98238, RP-DFCI-98238, NCI-G00-1779
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: William Oh, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
April 2003

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