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



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

For Condition: adenocarcinoma of the prostate,recurrent prostate cancer,stage 4 prostate cancer
Status: No longer recruiting
Sponsor(s): Heartland Cancer Research Network ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RajSadasivan,  Study Chair,  Heartland Cancer Research Network

Bethany Medical Center
Kansas City,  Kansas,  66102
United States
 

Heartland Cancer Research and Treatment Center
Kansas City,  Kansas,  66106
United States
 


Additional Information:
Study ID Numbers:  CDR0000066007;  HCRN-006,NCI-V98-1377
Study Start Date: March 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003183

Other Stage 4 Prostate Cancer Studies:
1. Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy

2. Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy

3. Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer

4. BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer

5. Hormone Therapy in Treating Men With Stage IV Prostate Cancer

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