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A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hormone-Refractory Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hormone-Refractory Prostate Cancer

OBJECTIVES: I. Determine the antitumor activity of DX-8951f as measured by PSA response in
patients with hormone refractory prostate cancer. II. Determine the antitumor activity of
this drug in the subpopulation of these patients with measurable disease. III. Evaluate the
quantitative and qualitative toxicities of this drug in these patients. IV. Evaluate the
pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for
5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable
toxicity or disease progression. Patients with no evidence of PSA decrease by the start of
course 3 receive no further treatment. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed prostate carcinoma
Metastatic disease Documented progression of prostate cancer while receiving androgen
ablative therapy (i.e., surgical or chemical castration and a serum testosterone level in
the castrate range) Documented hormone therapy resistance defined as: PSA rise on 3
occasions not less than 4 weeks apart Any evidence of progressive measurable disease PSA
must be above 20 ng/mL prior to study entry No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at
least 9.0 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5
mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver
metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active
congestive heart failure No uncontrolled angina No myocardial infarction within the past 6
months Other: Fertile patients must use effective contraception No uncontrolled pain
requiring irradiation No concurrent serious infection No other malignancy within the past
5 years except nonmelanoma skin cancer No overt psychosis, mental disability, or

PRIOR CONCURRENT THERAPY: Biologic therapy: No prophylactic colony stimulating factors to
prevent neutropenia No concurrent biologic therapy Chemotherapy: No more than 1 prior
cytotoxic chemotherapy regimen No concurrent cytotoxic chemotherapy Endocrine therapy: See
Disease Characteristics At least 6 weeks since prior peripheral antiandrogens (e.g.,
flutamide) No concurrent steroid therapy initiated within past 2 months Current LHRH
agonist therapy should continue through study Radiotherapy: At least 4 weeks since prior
radiotherapy (except low dose, non myelosuppressive) and recovered No prior irradiation to
greater than 25% of bone marrow No prior strontium chloride Sr 89 or samarium Sm 153
lexidronam pentasodium No concurrent radiotherapy Surgery: See Disease Characteristics At
least 4 weeks since prior major surgery and recovered No concurrent surgery Other: No
other concurrent anticancer treatment At least 28 days since investigational drugs,
including analgesics or antiemetics No other investigational drugs during and for 28 days
after study No concurrent drugs that induce or inhibit CYP3A enzyme No concurrent herbal
preparations (e.g., PC-SPES)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.


United States: Federal Government

Study ID:




Start Date:

June 1999

Completion Date:

August 2001

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



U.S. Oncology Research Inc. Houston, Texas  77060
Institute for Drug Development San Antonio, Texas  78245-3217