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CompletedNCT00005627Updated Jul 18, 2013

Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

A Phase 1 interventional study of carboplatin and docetaxel in Prostate Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 2 sites in United States. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-07-18.

Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years to 85 Years
Sex
Male
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • adenocarcinoma of the prostate
  • recurrent prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.

Browse Prostatic Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 123 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment

Interventions

  • Drugcarboplatin
  • Drugdocetaxel
  • Drugestramustine phosphate sodium
06

Study locations

2 sites
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
07

References and documents

Publications

  • 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. PubMed 15671557 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00005627
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Mar 1999
Completion
Apr 2003
Last update
Jul 18, 2013

Study contacts

William Oh, MD
study chair · Dana-Farber Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2003. You cannot join it, but the record below documents what was studied.

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