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A Phase I/II Trial Using Weekly Mitoxantrone Chemotherapy and G-CSF for the Treatment of Metastatic Hormone Refractory Prostate Cancer

Phase 1/Phase 2
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase I/II Trial Using Weekly Mitoxantrone Chemotherapy and G-CSF for the Treatment of Metastatic Hormone Refractory Prostate Cancer

OBJECTIVES: I. Study the effectiveness of mitoxantrone in patients with metastatic, hormone
refractory prostate cancer. II. Assess the side effects of mitoxantrone in this patient
population. III. Determine whether filgrastim (granulocyte colony-stimulating factor; G-CSF)
treatment can overcome chronic bone marrow suppression and facilitate a dose intensive
mitoxantrone chemotherapy regimen in this patient population.

OUTLINE: This is a dose escalation study. Patients receive a 30 minute intravenous infusion
of mitoxantrone once a week on day 1. On days 2-6 of each week, patients receive
subcutaneous filgrastim (granulocyte colony-stimulating factor; G-CSF). Treatment continues
for patients who respond to therapy and exhibit no disease progression. Dose escalation
proceeds until the maximum tolerated dose (MTD) of mitoxantrone with G-CSF support is
determined. The MTD is defined as the dose preceding that at which 2 or more patients
experience dose limiting toxicity. After the MTD is determined, an additional 20-40 patients
are enrolled at this dose level to examine their response to this therapy.

PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for the phase I portion of
this protocol. An additional 20-40 patients may be accrued for the phase II portion of this

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed hormone refractory adenocarcinoma of the
prostate Metastatic disease required

PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy:
Greater than 12 weeks Hematopoietic: Absolute granulocyte count greater than 1500/mm3
Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT less
than 2 times normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Must have
adequate cardiac function (LVEF at least 40%) Other: No other malignancy except skin
lesions that have been completely excised No prior hypersensitivity to E. coli derived

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: See Disease Characteristics At least 1 month since LHRH
agonist and/or flutamide Radiotherapy: No concurrent radiotherapy No prior extensive
radiotherapy (such as whole pelvic irradiation) Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Raj Sadasivan, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hope Cancer Institute, Inc.


United States: Federal Government

Study ID:




Start Date:

March 1997

Completion Date:

Related Keywords:

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



Bethany Medical Center Kansas City, Kansas  66102
Heartland Cancer Research and Treatment Center Kansas City, Kansas  66106