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Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma

Phase 2
18 Years
Open (Enrolling)
Urothelial Cancer

Thank you

Trial Information

Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma

Inclusion Criteria:

1. Has histological documentation of diagnosis of transitional cell carcinoma (TCC) of
the bladder, urethra, ureter, or renal pelvis (histology may be mixed, but still
requires a component of TCC; measurable disease only)

2. Has unresectable or metastatic disease

3. Has a Karnofsky Performance Status greater than or equal 60 percent

4. Is 18 years of age or older

5. Has laboratory values as defined by the protocol

6. Has resolution of all acute toxic effects of prior chemotherapy or radiotherapy or
surgical procedures to NCI CTCAE (v3.0) Grade less than or equal to 1

7. Has normal cardiac function as evidenced by a LVEF greater than or equal to 50
percent, as determined by multiple gated acquisition (MUGA) scan or an echocardiogram
(ECHO). The same method must be used throughout the study to evaluate LVEF.

8. Has a negative serum pregnancy test within 7 calendar days prior to registration
(female patients of childbearing potential [not surgically sterilized and between
menarche and 1 year postmenopause])

9. Is not currently breastfeeding

10. If fertile, patient (male or female) has agreed to use an acceptable method of birth
control to avoid pregnancy for the duration of the study and for a period of 3 months

11. Has signed a Patient Informed Consent Form, Has signed a Patient Authorization Form

Exclusion Criteria:

1. Has had prior treatment with systemic chemotherapy (prior intravesical therapy is

2. Has had major surgery or radiation therapy within 4 weeks of starting the study

3. Has had NCI CTCAE (Version 3.0) Grade 3-4 hemorrhage within 4 weeks of starting the
study treatment

4. Has a history of or known spinal cord compression, or carcinomatous meningitis, or
evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan.
However treated, stable and asymptomatic brain metastases are allowed.

5. Has had any of the following within the 6 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism

6. Has ongoing cardiac dysrhythmias of NCI CTCAE (Version 3.0) Grade 2

7. Has prolonged QTc interval on baseline EKG

8. Has uncontrolled hypertension (grater than 150/100 mm Hg despite optimal medical

9. Has pre-existing thyroid abnormality with thyroid function that cannot be maintained
in the normal range with medication

10. Has known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness or other active infection

11. Is receiving concomitant use of any other investigational drugs or has received such
drug within 28 days prior to registration

12. Is receiving concurrent treatment on another clinical trial, including supportive

13. Has ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2
mg PO daily for thromboembolic prohylaxis allowed). Patients on warfarin (greater
than 2mg) for thrombosis must be switched to low molecular weight heparin (ie,
Lovenox), prior to registration for protocol therapy.

14. Is currently taking drugs having proarrhythmic potential (terfenadine, quinidine,
procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone,
indapamide and flecainide) within 7 days prior to Day 1 of Cycle 1 (dosing) (and
throughout study)

15. Is currently on CYP3A4 inhibitors (see Section 5) within 7 days prior to Day 1 of
Cycle 1 (dosing), with the exception of amiodarone, which should be discontinued
within 6 months prior to Day 1 of Cycle 1 (dosing)

16. Is currently on CYP3A4 inducers (see Section 5) within 14 days prior to Day 1 of
Cycle 1 (dosing)

17. Has been taking herbal or alternative medications within the past 7 days or refuses
to discontinue the use of herbal or alternative therapies within 7 days prior to Day
1 of Cycle 1 (dosing)

18. Has a serious uncontrolled intercurrent medical or psychiatric illness, including
serious infection

19. Has a history of other malignancy within the last 5 years (except cured basal cell
carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the
diagnosis or assessment of any of the study drugs.

20. Is a pregnant or nursing woman. Patients must be surgically sterile or be
postmenopausal, or must agree to use effective contraception during the period of
therapy. The definition of effective contraception will be based on the judgment of
the Study Investigator or Treating Physician. Male patients must be surgically
sterile or agree to use effective contraception.

Is unable to comply with requirements of study

Type of Study:


Study Design:

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

Outcome Measure:

The primary objective of this nonrandomized Phase II study is to evaluate the objective response rate (ORR, CR+PR) in patients with advanced/metastatic UC treated with the combination of gemcitabine, cisplatin, and sunitinib.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Guru Sonpavde, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

June 2012

Related Keywords:

  • Urothelial Cancer



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Virginia Oncology Associates Newport News, Virginia  23606
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New York Oncology Hematology, P.C. Albany, New York  12208
Arizona Oncology Associates Tucson, Arizona  85712-2254
Hematology Oncology Associates of Illinois Skokie, Illinois  60077
Cancer Centers of Florida, P.A. Orlando, Florida  
Texas Oncology Dallas, Texas  
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota  55407
Hematology-Oncology Associates of Northern NJ, PA Morristown, New Jersey  07962
Medical Oncology Associates of Wyoming Valley, PC Kingston, Pennsylvania  18704
Highline Medical Oncology Burien, Washington  98166
Arch Medical Services, INC. St. Louis, Missouri  63142
Texas Cancer Center Abilene, Texas  79606
Longview Cancer Center Longview, Texas  75601
Raleigh Hematology Oncology Associates Cary, North Carolina  27511
Deke Slayton Cancer Center Webster, Texas  77589
Northwest Cancer Specialists, PC Vancouver, Washington  98684
Texas Cancer Center - Abilene Abilene, Texas  79606
Texas Cancer Center - Sherman Sherman, Texas  75090-0504
Oncology & Hematology Associates of Southwest Virginia, Inc. Salem, Virginia  24153
Cancer Care Centers of South Texas San Antonio, Texas  78229
Cancer Care & Hematology Specialists of Chicagoland Niles, Illinois  60714
Texas Oncology - Round Rock Cancer Center Round Rock, Texas  78681
Texas Oncology, P.A. - Bedford Bedford, Texas  76022
Advanced Medical Specialties Miami, Florida  33176
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Florida Cancer Institute - New Hope New Port Richey, Florida  34655
Cancer Care Centers of South Texas-HOAST San Antonio, Texas  78229
South Texas Cancer Center Corpus Christi, Texas  78405
Texas Oncology Cancer Center - Sugar Land Sugar Land, Texas  77479
Texas Oncology, P.A. -Amarillo Amarillo, Texas  79106
Alliance Hematology Oncology PA. Westminster, Maryland  21157
Mamie McFaddin Ward Cancer Center, Texas Oncology Beaumont, Texas  77702
Texas Oncology/Methodist Charlton Cancer Ctr. Dallas, Texas  75237
El Paso Cancer Treatment Center - East El Paso, Texas  79915
Texas Oncology, PA, Allison Cancer Center Midland, Texas  79701
Pudget Sound Cancer Center Edmonds, Washington  98026