Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer

NCT00005958 | Unknown Phase 2

• 3 other identifiers: CDR0000067939AMGEN-GCSF-990125NCI-V00-1594
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 12

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with gemcitabine and docetaxel plus filgrastim in treating patients who have locally recurrent or advanced urothelium cancer.

Conditions

Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter

Keywords

stage III bladder cancer; recurrent bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder; metastatic transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter; recurrent transitional cell cancer of the renal pelvis and ureter

Interventions

filgrastim BIOLOGICAL

docetaxel DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven locally recurrent or advanced transitional cell carcinoma (TCC) of the urothelial tract (bladder, renal pelvis, or ureter) or TCC with squamous cell or glandular elements not amenable to curative treatment No pure squamous cell carcinoma or adenocarcinoma Regional or distant metastases after cystoprostatectomy No brain metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 80-100% Life expectancy: At least 3 months Hematopoietic: No hemorrhagic disorder Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10.0 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known sensitivity to any products to be administered or E. coli derived products No prior other malignancy except inactive nonmelanoma skin cancer, adequately treated stage I or II cancer in complete remission, or early stage prostate cancer (not currently being treated) No illness or psychiatric condition that would preclude study or follow up Not previously entered in this study No active uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent biologic therapy No concurrent WBC transfusions Chemotherapy: No prior gemcitabine or docetaxel Other prior chemotherapy allowed Prior intravesical therapy allowed No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy to renal pelvis or ureter allowed Surgery: See Disease Characteristics Cystoprostatectomy or nephroureterectomy for localized TCC allowed Other: No prior investigational drugs No other concurrent investigational therapy No concurrent acetaminophen for fever prophylaxis

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

Sponsors & Collaborators

• Amgen: lead

Study Sites (12)

University of California San Diego

La Jolla, California, 92093, United States

Location

Sacramento Center for Hematology and Medical Oncology

Sacramento, California, 95819, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Center for Hematology-Oncology

Boca Raton, Florida, 33486, United States

Location

Oncology-Hematology Associates of North Illinois, Ltd.

Gurnee, Illinois, 60031, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074, United States

Location

St. Joseph Medical Center

Towson, Maryland, 21204, United States

Location

Hematology & Oncology Associates of Southern Michigan

Jackson, Michigan, 49201, United States

Location

Hematology Oncology Associates of Central New York

Syracuse, New York, 13217-6962, United States

Location

Memphis Cancer Center, Inc.

Memphis, Tennessee, 38119, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012, United States

Location

Northern Virginia Oncology Group

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Filgrastim; Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic 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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jennifer Tam

  Amgen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: April 20, 2004
• Study Start: October 1, 1999
• Last Updated: December 4, 2013

Record last verified: 2001-10

Locations

US (12)