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PHASE I/II STUDY OF DOCETAXEL (TAXOTERE) AND ESTRAMUSTINE COMBINATION CHEMOTHERAPY IN PATIENTS WITH PROSTATE CANCER


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

PHASE I/II STUDY OF DOCETAXEL (TAXOTERE) AND ESTRAMUSTINE COMBINATION CHEMOTHERAPY IN PATIENTS WITH PROSTATE CANCER


OBJECTIVES: I. Determine the maximum tolerated dose, toxicity, and pharmacokinetic profile
of docetaxel in combination with estramustine in patients with metastatic adenocarcinoma of
the prostate. II. Determine the safe dose level of this regimen for Phase II evaluation.
III. Determine the efficacy of this regimen with evaluation of objective response rate,
duration of response, and time to disease progression in these patients. IV. Determine the
duration of survival of these patients on this regimen. V. Evaluate the symptomatic and
quality of life effects in these patients.

OUTLINE: This is a dose escalation study (phase I). Patients are stratified into one of two
risk groups by number of prior chemotherapy regimens (0-2 vs greater than 2) and occurrence
and site(s) of prior radiation. Patients receive oral estramustine three times daily
beginning 24 hours prior to docetaxel and continuing for 4 days after infusion. Patients
receive docetaxel IV over 1 hour every 21 days. Cohorts of 3-6 patients receive escalating
doses of docetaxel until the maximum tolerated dose (MTD) is reached (phase I). The MTD is
defined as the dose preceding that at which 2 of 6 patients experience dose limiting
toxicity. A minimum of 6 patients receive treatment at the MTD. Phase II: Patients receive
docetaxel IV at the MTD from phase I. Treatment continues in the absence of disease
progression or unacceptable toxicity for both phases. Quality of life is assessed. Patients
are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 12-37 patients will be accrued for this study within 13-19
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the
prostate Failure of androgen ablation (orchiectomy or luteinizing hormone releasing
hormone, flutamide) -Rise in PSA greater than 50% of nadir confirmed by 2 measurements 1
week apart -Appearance of new soft tissue lesions -Appearance of new lesions on bone scan
Measurable or evaluable disease No symptomatic ascites, pleural effusions, or peripheral
edema greater than trace No brain or leptomeningeal involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 No history of coagulopathy Hepatic:
Bilirubin no greater than upper limit of normal (ULN) SGOT or SGPT no greater than 2.0
times ULN Alkaline phosphatase no greater than 5.0 times ULN Renal: Creatinine no greater
than 2.0 times ULN Cardiovascular: No myocardial infarction within past 6 months
Pulmonary: No prior pulmonary embolus Neurologic: No prior cerebrovascular accident No
symptomatic peripheral neuropathy greater than grade 1 No significant neurologic or
psychiatric disorder (psychotic disorder, dementia, or seizure) Other: No other prior
malignancy within past 5 years, except: Excised or curatively irradiated nonmelanomatous
skin cancer No other serious illness or medical condition No active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy
Radiotherapy: At least 4 weeks since prior radiotherapy At least 6 weeks since prior
isotope therapy No prior radiotherapy to greater than 30% of bone marrow Surgery: Not
specified Other: At least 4 weeks since prior investigational drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Daniel P. Petrylak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064755

NCT ID:

NCT00002775

Start Date:

February 1998

Completion Date:

Related Keywords:

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

Name

Location

Herbert Irving Comprehensive Cancer CenterNew York, New York  10032