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| Sponsored by: |
Hope Cancer Institute |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003183 |
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: filgrastim Drug: mitoxantrone hydrochloride |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I/II Trial Using Weekly Mitoxantrone Chemotherapy and G-CSF for the Treatment of Metastatic Hormone Refractory Prostate Cancer |
| Estimated Enrollment: | 64 |
| Study Start Date: | 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.
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| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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| United States, Kansas | |
| Bethany Medical Center | |
| Kansas City, Kansas, United States, 66102 | |
| Heartland Cancer Research and Treatment Center | |
| Kansas City, Kansas, United States, 66106 | |
| Study Chair: | Raj Sadasivan, MD, PhD | Hope Cancer Institute |
More Information
| Study ID Numbers: | CDR0000066007, HCRN-006, NCI-V98-1377 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003183 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
|
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Peripheral Nervous System Agents Analgesics Mitoxantrone |
Genital Diseases, Male Adenocarcinoma Hormones Prostatic Neoplasms Recurrence |
|
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions Neoplasms |
Neoplasms by Site Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Mitoxantrone Analgesics Central Nervous System Agents Prostatic Neoplasms |
