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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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