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Safety and Efficacy of One Hour Weekly Taxol Infusion and Estramustine in Hormone Refractory Prostate Cancer

Phase 1
Not Enrolling
Prostate Cancer

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Trial Information

Safety and Efficacy of One Hour Weekly Taxol Infusion and Estramustine in Hormone Refractory Prostate Cancer

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of paclitaxel with estramustine in
patients with hormone refractory prostate cancer. II. Evaluate the toxicity of this
combination at the MTD of paclitaxel in this patient population. III. Determine any
objective tumor response arising from this treatment in these patients.

OUTLINE: This is a dose escalation study of paclitaxel. Patients receive oral estramustine
daily on days 1-3 and paclitaxel IV over 1 hour on day 3 weekly for 6 weeks followed by 1
week of rest. Treatment continues for at least 2 courses in the absence of unacceptable
toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of
paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: A minimum of 18 patients will be accrued for this study within 18 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate with
progressive systemic disease despite at least 1 endocrine manipulation including 1 of the
following: Orchiectomy LHRH analogue with or without flutamide, megestrol, or
diethylstilbestrol Flutamide must be discontinued for at least 2 weeks with PSA stabilized
above normal or rising Measurable or evaluable disease No brain metastasis

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Greater than 2 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin greater than 1 mg/dL SGOT greater than 2 times
upper limit of normal Renal: Creatinine less than 2 mg/dL Hydronephrosis with impaired
renal function must be decompressed adequately Cardiovascular: No severe cardiac (i.e.,
symptomatic arrhythmia requiring medication or active congestive heart failure) or
coronary disease that are unstable despite medication Other: Adequate nutritional status
(at least 1,500 Kcal/day) No other significant active medical illness that would preclude
study therapy or survival No other malignancy within the past 5 years except adequately
treated basal or squamous cell carcinoma of the skin No acute spinal cord compression

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifiers
Chemotherapy: No other concurrent chemotherapy Endocrine therapy: See Disease
Characteristics At least 2 weeks since prior corticosteroids No concurrent exogenous
corticosteroids except for documented CNS metastases or adrenal insufficiency Concurrent
hormones for nondisease conditions allowed (e.g., insulin for diabetes mellitus)
Concurrent continuation of monthly hormonal therapy with an LHRH agonist or DES required
Radiotherapy: Prior radiation to symptomatic metastatic site allowed provided it is not
the only measurable or evaluable lesion At least 2 weeks since prior radiotherapy and
recovered No concurrent radiotherapy No concurrent palliative radiotherapy except for
whole brain irradiation for documented CNS disease or impending spinal cord compression
Surgery: See Disease Characteristics At least 3 weeks since prior surgery and recovered
Other: No other concurrent treatment for prostate cancer except pain palliation

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Abraham Chachoua, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

April 1997

Completion Date:

Related Keywords:

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



Kaplan Cancer Center New York, New York  10016
Mount Sinai Medical Center, NY New York, New York  10029