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Mitoxantrone and G-CSF in Treating Patients With Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00003183
Recruitment Status : Unknown
Verified April 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : May 19, 2004
Last Update Posted : December 4, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Biological: filgrastim Drug: mitoxantrone hydrochloride Phase 1 Phase 2

Detailed Description:

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 study.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Primary Purpose: Treatment
Official Title: A Phase I/II Trial Using Weekly Mitoxantrone Chemotherapy and G-CSF for the Treatment of Metastatic Hormone Refractory Prostate Cancer
Study Start Date : March 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 products

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003183


Locations
United States, Kansas
Bethany Medical Center
Kansas City, Kansas, United States, 66102
Heartland Cancer Research and Treatment Center
Kansas City, Kansas, United States, 66106
Sponsors and Collaborators
Hope Cancer Institute, Inc.
Investigators
Study Chair: Raj Sadasivan, MD, PhD Hope Cancer Institute, Inc.
More Information

ClinicalTrials.gov Identifier: NCT00003183     History of Changes
Other Study ID Numbers: CDR0000066007
HCRN-006
NCI-V98-1377
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: April 2001

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Mitoxantrone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action