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

NCT00003183 | Unknown Phase 1

• 3 other identifiers: CDR0000066007HCRN-006NCI-V98-1377
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer

Interventions

filgrastim BIOLOGICAL

mitoxantrone hydrochloride DRUG

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Hope Cancer Institute, Inc.: lead

Study Sites (2)

Bethany Medical Center

Kansas City, Kansas, 66102, United States

Location

Heartland Cancer Research and Treatment Center

Kansas City, Kansas, 66106, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Filgrastim; Mitoxantrone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds

Study Officials

• Raj Sadasivan, MD, PhD

  Hope Cancer Institute, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 19, 2004
• Study Start: March 1, 1997
• Last Updated: December 4, 2013

Record last verified: 2001-04

Locations

US (2)