Not Signed In -
Gemcitabine Hydrochloride |
Gemzar |
Clinical Trial: Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
This study is currently recruiting patients.
Purpose
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have advanced cancer of the urothelium.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Bladder Cancer transitional cell cancer of the renal pelvis and ureter Urethral Cancer | Drug: gemcitabine Drug: pemetrexed disodium Procedure: chemotherapy Procedure: enzyme inhibitor therapy | Phase II |
MedlinePlus related topics: Bladder Cancer; Cancer; Kidney Cancer
Genetics Home Reference related topics: bladder cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Pemetrexed Disodium and Gemcitabine in Patients With Advanced Cancer of the Urothelium
Further Study Details:
OBJECTIVES: Primary
- Determine the response rate in patients with previously untreated advanced cancer of the urothelium treated with pemetrexed disodium and gemcitabine.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine the overall survival and time to progression in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive cyanocobalamin intramuscularly once every 9 weeks and folic acid orally once daily beginning on day -6 and continuing until 3 weeks after the completion of study therapy. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 24-46 patients will be accrued for this study within 15 -18 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
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
Location and Contact Information
Alabama
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States; Recruiting
Carla I. Falkson, MD 205-975-2691 cfalkson@uab.edu
Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States; Recruiting
Tom Robert Fitch, MD 480-301-9875
California
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Clinical Trials Office - New Patient Services 800-826-4673 becomingapatient@coh.org
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305-5216, United States; Recruiting
Harlan A. Pinto, MD 650-725-9057
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, 94304-1290, United States; Recruiting
Harlan A. Pinto, MD 650-493-5000 ext. 4948
Colorado
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, 80224, United States; Recruiting
Eduardo R. Pajon, MD 303-777-2663 erpajon@aol.com
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Lucile L. Adams-Campbell, PhD 202-806-7697
Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, 33612-9497, United States; Recruiting
Cancer Answers 800-456-7121
Veterans Affairs Medical Center - Gainesville, Gainesville, Florida, 32608-1197, United States; Recruiting
Dean Latain McCarley, MD 352-374-6016
Veterans Affairs Medical Center - Miami, Miami, Florida, 33125, United States; Recruiting
Niramol Savaraj, MD 305-575-3143 nsavaraj@med.miami.edu
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Julie A. Kish, MD, FACP 813-972-2000
Georgia
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, 30033, United States; Recruiting
Maria Jose Amarante Ribeiro, MD 404-728-7680 maria.ribeiro@med.va.gov
Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322, United States; Recruiting
William Costin Wood, MD 404-778-5180
Illinois
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, MD 217-383-4083 kendrith.rowland@carle.com
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
James L. Wade, MD 217-876-6617 jlwade3@sbcglobal.net
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
Gershon Y. Locker, MD, FACP 847-570-2518 glocker@enh.org
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
John W. Kugler, MD 309-243-3605
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, 60521, United States; Recruiting
Elyse Cheryl Schneiderman, MD 630-654-1790
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, 60611, United States; Recruiting
Al Bowen Benson, MD, FACP 312-695-1382
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, 60611-4494, United States; Recruiting
Timothy M. Kuzel, MD 312-469-3748
Indiana
Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States; Recruiting
Patrick J. Loehrer, MD 317-278-7418
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, 46202, United States; Recruiting
Patrick J. Loehrer, MD 317-554-0000
Iowa
Burgess Health Center, Onawa, Iowa, 51040, United States; Recruiting
James A. Mailliard, MD 712-423-2311
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States; Recruiting
Martin Wiesenfeld, MD 319-363-8303
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-244-7586
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, 50316-2301, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-663-5612
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, 50309, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-241-4245
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, 50314, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-247-3121
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-268-5784
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-685-2221
Louisiana
CCOP - Ochsner, New Orleans, Louisiana, 70121, United States; Recruiting
Carl G. Kardinal, MD 504-842-3910
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Jill Gilbert, MD 504-568-5613 jgilbe@lsuhsc.edu
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Michael Benjamin Atkins, MD 617-667-1930
Cancer Center at Tufts - New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
John K. Erban, MD 617-636-5147 jerban@tufts-nemc.org
Michigan
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
Raymond Sterling Lord, MD 269-373-7488 rlord@wmcc.org
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237 beekmanl@trinity-health.org
Minnesota
CCOP - Duluth, Duluth, Minnesota, 55805, United States; Recruiting
Robert J. Dalton, MD 218-786-8364 rdalton@smdc.org
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn, MD 952-993-1517 patrick.flynn@usoncology.com
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
Thomas M. Habermann, MD 507-284-2511
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
George L. Adams, MD 612-625-2410 adams002@umn.edu
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417-2399, United States; Recruiting
Markus Gapany, MD, FACS 612-725-2000 ext. 3459 gapan001@maroon.tc.umn.edu
Nebraska
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106, United States; Recruiting
James A. Mailliard, MD 402-280-4364 jamailliard@mrcc.cc
Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska, 68128-4157, United States; Recruiting
James A. Mailliard, MD 402-593-3000
Veterans Affairs Medical Center - Omaha, Omaha, Nebraska, 68105, United States; Recruiting
James A. Mailliard, MD 402-280-5274
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
John Allan Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
Camilo E. Fadul, MD 603-650-6312 Camilo.e.fadul@dartmouth.edu
New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
Joseph Aisner, MD 732-235-7401 aisnerjo@umdnj.edu
CCOP - Northern New Jersey, Hackensack, New Jersey, 07601, United States; Recruiting
Richard J. Rosenbluth, MD 201-996-5917
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, 07018, United States; Recruiting
Basil S. Kasimis, MD, DSc 973-676-1000 ext. 7095 Basil.Kasimis@med.va.gov
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Cynthia K. Cathcart, MD 505-272-5688
New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States; Recruiting
Joseph A. Sparano, MD 718-904-2555 jsparano@montefiore.org
MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York, 10466, United States; Recruiting
Peter H. Wiernik, MD 718-920-9900 pwiernik@olmhs.org
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Howard S. Hochster, MD 212-731-5100 howard.hochster@med.nyu.edu
Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York, 11209, United States; Recruiting
Andrea Nadine Wiesel Leaf, MD 718-630-3691
Veterans Affairs Medical Center - New York, New York, New York, 10010, United States; Recruiting
Howard S. Hochster, MD 212-652-1912 howard.hochster@med.nyu.edu
North Dakota
CCOP - Merit Care Hospital, Fargo, North Dakota, 58122, United States; Recruiting
Preston D. Steen, MD 701-234-6298 prestonsteen@meritcare.com
Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
J. Philip Kuebler, MD, PhD 614-488-2118
CCOP - Toledo Community Hospital, Toledo, Ohio, 43623-3456, United States; Recruiting
Paul L. Schaefer, MD 419-843-6147
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195, United States; Recruiting
Robert Dreicer, MD, FACP 216-445-4623
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
Edward G. Mansour, MD 216-778-4394 emansour@metrohealth.org
Oklahoma
CCOP - Oklahoma, Tulsa, Oklahoma, 74136, United States; Recruiting
James B. Lockhart, MD 918-491-5878
Pennsylvania
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Daniel G. Haller, MD 215-662-6318
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Albert M. Bernath, MD 570-271-6466
CCOP - MainLine Health, Wynnewood, Pennsylvania, 19096, United States; Recruiting
Paul B. Gilman, MD 610-645-2494
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111-2497, United States; Recruiting
Lori J. Goldstein, MD 215-728-2689 lj_goldstein@fccc.edu
Hahnemann University Hospital, Philadelphia, Pennsylvania, 19102-1192, United States; Recruiting
Pamela Ann Crilley, DO 215-762-8547
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15236, United States; Recruiting
John Munn Kirkwood, MD 412-692-4724
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States; Recruiting
Witold Boleslaw Rybka, MD, FRCPC 717-531-1050 wrybka@med.hmc.psu.edu
Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania, 15240, United States; Recruiting
Timothy Carlos, MD 412-688-6248 timothy.carlos@med.va.gov
South Dakota
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57104, United States; Recruiting
Loren K. Tschetter, MD 605-328-8044 tidemanb@siouxvalley.org
Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-6307, United States; Recruiting
Bruce J. Roth, MD 615-343-4070
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville, Tennessee, 37212-2637, United States; Recruiting
Kenneth R. Hande, MD 615-327-4751
Wisconsin
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
Tarit Kumar Banerjee, MD, FACP 715-387-5511
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, 54301, United States; Recruiting
Gerald K. Bayer, MD 920-433-8889
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, 53226-3596, United States; Recruiting
David H. Vesole, MD, PhD 414-805-4626 dvesole@bmt.mcw.edu
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-0001, United States; Recruiting
James A. Stewart, MD 608-265-8131 stewart@biostat.wisc.edu
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, 53705, United States; Recruiting
Mark R. Albertini, MD 608-262-7017
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, 53295, United States; Recruiting
Mohammed A. Raheem, MD 414-384-2000
Australia, New South Wales
Westmead Breast Centre at NSW Breast Cancer Institute, Westmead, New South Wales, 2145, Australia; Recruiting
Michael B. Barton, MD 61-2-9845-5555 barton@radonc.ish.su.edu
Westmead Hospital, Westmead, New South Wales, 2145, Australia; Recruiting
Richard Kefford, MD, PhD 61-2-9845-6033
Peru
Instituto de Enfermedades Neoplasicas, Lima, 34, Peru; Recruiting
Carlos Santiago Vallejos-Sologuren, MD 51-14-499-137 postmaster@inen.sld.pe
Puerto Rico
MBCCOP - San Juan, San Juan, 00921-3201, Puerto Rico; Recruiting
Luis Baez-Diaz, MD 787-641-3693 sjccop@prtc.net
San Juan City Hospital, San Juan, 00936-7344, Puerto Rico; Recruiting
Luis Baez-Diaz, MD 787-641-3693 sjccop@prtc.net
Veterans Affairs Medical Center - San Juan, San Juan, 00927-5800, Puerto Rico; Recruiting
Luis Baez-Diaz, MD 787-641-7582 sjccop@prtc.net
South Africa
Pretoria Academic Hospital, Pretoria, 0001, South Africa; Recruiting
Coenraad Frederick Slabber, MD 27-12-354-1054
Study chairs or principal investigators
Robert Dreicer, MD, FACP, Study Chair, Cleveland Clinic Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000269302; ECOG-E4802; NCT00053209
Record last reviewed: February 2005
Last Updated: April 4, 2005
Record first received: January 27, 2003
ClinicalTrials.gov Identifier: NCT00053209
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: February 2005
Last Updated: April 4, 2005
Record first received: January 27, 2003
ClinicalTrials.gov Identifier: NCT00053209
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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