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A Phase I Study of Estramustine, Taxotere and Carboplatin (ETP) in Patients With Horomone Refractory Prostate Cancer


Phase 1
18 Years
85 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Phase I Study of Estramustine, Taxotere and Carboplatin (ETP) in Patients With Horomone Refractory Prostate Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William Oh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067775

NCT ID:

NCT00005627

Start Date:

March 1999

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber Cancer InstituteBoston, Massachusetts  02115