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Phase II Trial Of Sequential Estramustine/Paclitaxel Followed By Doxorubicin/Ketoconazole In Patients With Androgen-Independent Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer, Thromboembolism

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Trial Information

Phase II Trial Of Sequential Estramustine/Paclitaxel Followed By Doxorubicin/Ketoconazole In Patients With Androgen-Independent Prostate Cancer


OBJECTIVES: I. Determine the safety, efficacy, and durability of docetaxel and estramustine
followed by doxorubicin and ketoconazole in patients with high-risk, androgen-independent
prostate cancer. II. Determine whether anticoagulation with warfarin can reduce the
frequency of thromboembolic complications associated with estramustine in these patients.

OUTLINE: Regimen A: Patients receive oral estramustine 3 times daily on days 1-5 and
docetaxel IV over 1 hour on day 3 weekly. Patients also receive oral warfarin daily.
Treatment repeats every 4 weeks for a total of 2 courses in the absence of disease
progression or unacceptable toxicity. Regimen B: After completion of regimen A, patients
receive doxorubicin IV over 30 minutes weekly and oral ketoconazole twice daily. Treatment
repeats every 4 weeks for a total of 2 courses in the absence of disease progression or
unacceptable toxicity. Patients are followed monthly until disease progression.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer High risk as defined by
any 2 of the following: Karnofsky performance status of 70-80% Lactate dehydrogenase
greater than 200 U/mL Hemoglobin less than 13 g/dL Prostate-specific antigen (PSA) at
least 4 ng/mL Progressive disease based on any 1 of the following: Rise in PSA level of at
least 25% above baseline At least 3 determinations taken at weekly intervals OR At least 2
determinations taken at monthly intervals New or progressive soft tissue masses on MRI or
CT scan Radionucleotide bone scan with new metastatic lesion(s) Serum testosterone no
greater than 30 ng/mL If no prior surgical orchiectomy, castrate levels of serum
testosterone must be maintained with continuation of gonadotropin releasing hormone
analogs If receiving an anti-androgen, must show progression of disease after stopping
anti-androgen therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: See Disease Characteristics
Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: See Disease
Characteristics WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin normal SGOT/SGPT no greater than 1.5 times upper limit of normal (ULN) Renal:
Creatinine no greater than 1.5 times ULN Cardiovascular: No significant cardiovascular
disease No New York Heart Association class III or IV heart disease No active angina
pectoris No myocardial infarction within the last 6 months Ejection fraction at least 45%
by echocardiogram or MUGA No prior hemorrhagic or thrombotic cerebral vascular accident No
deep venous thrombosis Pulmonary: No pulmonary embolism within the past 6 months Other: No
history of bleeding disorder or gastrointestinal bleeding that would preclude
anticoagulation with warfarin No other concurrent malignancy except non-melanoma skin
cancer or any curatively treated malignancy considered to be at less than 30% risk of
relapse No severe infection No severe malnutrition No other serious medical illness that
would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1
prior chemotherapy regimen Endocrine therapy: See Disease Characteristics Radiotherapy: No
more than 1 prior course of palliative radiotherapy No more than 1 prior radioisotope
therapy with strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium Surgery:
See Disease Characteristics At least 4 weeks since prior major surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William K. Kelly, DO

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-113

NCT ID:

NCT00014352

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Thromboembolism
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • thromboembolism
  • Prostatic Neoplasms
  • Thromboembolism

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021