Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, transitional cell carcinoma of the bladder, recurrent bladder cancer, stage III bladder cancer, stage IV bladder cancer, anterior urethral cancer, posterior urethral cancer, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed cancer of the urothelium (renal pelvis, ureter, bladder, or urethra) Any of the following types: Transitional cell carcinoma (TCC) Mixed histologies containing a component of TCC Non-TCC of the urothelium (renal pelvis, ureter, bladder, or urethra) Progressing regional or metastatic disease Measurable disease No clinical evidence of CNS metastases No evidence of clinically significant (by physical exam or plain film) third-space fluid collections (pleural effusions or ascites) PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic AST no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal Creatinine clearance at least 45 mL/min Cardiovascular No history of severe cardiovascular disease (i.e., American Heart Association class III or IV heart disease) No uncontrolled congestive heart failure No ventricular dysrhythmias Other Not pregnant or nursing Fertile patients must use effective contraception No active unresolved infection No other prior malignancy unless curatively treated and disease free for an appropriate (disease-specific) period of time Able and willing to receive folic acid and cyanocobalamin supplementation PRIOR CONCURRENT THERAPY: Biologic therapy No prior systemic biologic response modifier therapy Chemotherapy No prior systemic chemotherapy for metastatic disease More than 1 year since prior neoadjuvant or adjuvant chemotherapy Endocrine therapy Not specified Radiotherapy At least 4 weeks since prior radiotherapy and recovered No prior pelvic radiotherapy No concurrent radiotherapy Surgery At least 4 weeks since prior major surgery and recovered Other More than 7 days since prior parenteral antibiotics No salicylates for 2 days before, during, and for 2 days after administration of pemetrexed disodium No nonsteroidal anti-inflammatory drugs for at least 5 days before, during, and for 2 days after administration of pemetrexed disodium
Sites / Locations
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program, Incorporated
- Swedish Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- St. Mary-Corwin Regional Medical Center
- North Suburban Medical Center
- Yale Comprehensive Cancer Center at Yale University School of Medicine
- Beebe Medical Center
- CCOP - Christiana Care Health Services
- St. Francis Hospital
- Baptist Cancer Institute - Jacksonville
- Watson Clinic, LLC
- Hematology and Oncology of Northeast Georgia
- MBCCOP-Medical College of Georgia Cancer Center
- Rush-Copley Cancer Care Center
- Hinsdale Hematology Oncology Associates
- Joliet Oncology Hematology Associates, Limited - West
- Regional Cancer Center at Memorial Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Elkhart General Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- Saint Joseph Regional Medical Center - Plymouth Campus
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- McFarland Clinic, P.C.
- Siouxland Regional Cancer Center
- Siouxland Hematology-Oncology Associates
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas, P.A. - El Dorado
- Cancer Center of Kansas - Kingman
- Southwest Medical Center
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas, P.A. - Parsons
- Pratt Cancer Center of Kansas
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates in Womens Health
- Cancer Center of Kansas, P.A.
- Cancer Center of Kansas, P.A. - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas - Winfield
- Union Hospital Cancer Center at Union Hospital
- Green Bay Oncology, Limited - Escanaba
- Green Bay Oncology, Limited - Iron Mountain
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- MeritCare Clinic - Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- CCOP - Duluth
- Miller-Dwan Medical Center
- St. Mary's - Duluth Clinic Cancer Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- St. John's Hospital
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- CCOP - Metro-Minnesota
- Park Nicollet Health Services
- Regions Hospital Cancer Care Center
- St. Joseph's Hospital
- United Hospital
- Saint Francis Cancer Center
- Ridgeview Medical Center
- Woodwinds Hospital
- Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
- Veterans Affairs Medical Center - East Orange
- CCOP - Northern New Jersey
- Cancer Institute of New Jersey at Hamilton
- Fox Chase Virtua Health Cancer Program - Marlton
- Mountainside Hospital Cancer Center
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Overlook Hospital
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- CCOP - MeritCare Hospital
- MeritCare Medical Group
- Aultman Hospital Cancer Center at Aultman Health Foundation
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
- Cleveland Clinic Taussig Cancer Center
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- St. Luke's Hospital Cancer Center
- Central Pennsylvania Hematology and Medical Oncology Associates, P. C.
- Abramson Cancer Center of the University of Pennsylvania
- Fox Chase-Temple Cancer Center
- Chester County Hospital
- Reading Hospital and Medical Center
- Cancer Care Institute of Carolina at Aiken Regional Medical Centers
- Sioux Valley Hospital and University of South Dakota Medical Center
- Avera McKennan Hospital and University Health Center
- Medical X-Ray Center
- Erlanger Cancer Center
- Vanderbilt-Ingram Cancer Center
- CCOP - Scott and White Hospital
- Green Bay Oncology, Limited at St. Vincent Hospital
- St. Vincent Hospital
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- University of Wisconsin Comprehensive Cancer Center
- Cancer Care Center at Holy Family Memorial Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
Arms of the Study
Arm 1
Experimental
Pemetrexed Disodium and Gemcitabine
Pemetrexed disodium 500 mg/m2 followed by gemcitabine 1000 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on day 8 of a 21-day cycle for a maximum of 6 cycles