Mitoxantrone |
Novantrone |
Clinical Trial: Mitoxantrone and G-CSF in Treating Patients With Metastatic Prostate Cancer
This study is no longer recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with G-CSF may make tumor cells more sensitive to the chemotherapy drug and may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of mitoxantrone plus G-CSF in treating patients with metastatic prostate cancer that has not responded to hormone therapy.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage IV prostate cancer adenocarcinoma of the prostate recurrent prostate cancer | Drug: filgrastim Drug: mitoxantrone | Phase I Phase II |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of Mitoxantrone with Filgrastim (G-CSF) Support in Patients with Metastatic, Hormone Refractory Prostate Cancer
Study start: March 1997
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.
PROTOCOL 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 study.
Eligibility
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically confirmed hormone refractory adenocarcinoma of the prostate
- Metastatic disease required
--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
--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 products
Location Information
Kansas
Bethany Medical Center, Kansas City, Kansas, 66102, United States
Heartland Cancer Research and Treatment Center, Kansas City, Kansas, 66106, United States
Raj Sadasivan, Study Chair, Heartland Cancer Research Network
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003183
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Mitoxantrone (Drug Digest)
- Novantrone (Drug Digest)

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