Know Cancer

or
forgot password

Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Thank you

Trial Information

Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response as measured by RECIST criteria

Outcome Time Frame:

Assessed every 6 weeks

Safety Issue:

No

Principal Investigator

Robert Dreicer, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000269302

NCT ID:

NCT00053209

Start Date:

April 2004

Completion Date:

May 2009

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • 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
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
North Suburban Medical CenterThornton, Colorado  80229
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
CCOP - MeritCare HospitalFargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Memorial Hospital of South BendSouth Bend, Indiana  46601
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Overlook HospitalSummit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Fox Chase-Temple Cancer CenterPhiladelphia, Pennsylvania  19111-2442
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
Chester County HospitalWest Chester, Pennsylvania  19380
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - KingmanKingman, Kansas  67068
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Pratt Cancer Center of KansasPratt, Kansas  67124
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A.Wichita, Kansas  67208
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Medical X-Ray CenterSioux Falls, South Dakota  57105
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
Yale Comprehensive Cancer Center at Yale University School of MedicineNew Haven, Connecticut  06520-8064
Elkhart General HospitalElkhart, Indiana  46515
Cancer Institute of New Jersey at the Cooper University Hospital - VoorheesCamden, New Jersey  08103
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
Beebe Medical CenterLewes, Delaware  19958
St. Francis HospitalWilmington, Delaware  19805
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Union Hospital Cancer Center at Union HospitalElkton MD, Maryland  21921
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Mountainside Hospital Cancer CenterMontclair, New Jersey  07042
MeritCare Medical GroupFargo, North Dakota  58122
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
McFarland Clinic, P.C.Ames, Iowa  50010
Miller-Dwan Medical CenterDuluth, Minnesota  55805
St. John's HospitalMaplewood, Minnesota  55109
Saint Joseph Regional Medical Center - Plymouth CampusPlymouth, Indiana  46544
Saint Francis Cancer CenterShakopee, Minnesota  55379
St. Joseph's HospitalSt Paul, Minnesota  55102
Woodwinds HospitalWoodbury, Minnesota  55125
St. Mary's Hospital Medical CenterGreen Bay, Wisconsin  54303
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Cancer Care Institute of Carolina at Aiken Regional Medical CentersAiken, South Carolina  29801
Watson Clinic, LLCLakeland, Florida  33804-5000
Hematology and Oncology of Northeast GeorgiaAthens, Georgia  30607
Erlanger Cancer CenterChattanooga, Tennessee  37403
Central Pennsylvania Hematology and Medical Oncology Associates, P. C.Lemoyne, Pennsylvania  17043
Cancer Care Center at Holy Family Memorial Medical CenterManitowoc, Wisconsin  54221