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Gemzar, Cisp, Sunitinib Urothelial Ca
This study is currently recruiting participants.
Verified by US Oncology Research, January 2009
First Received: January 9, 2009   No Changes Posted
Sponsors and Collaborators: US Oncology Research
Pfizer
Information provided by: US Oncology Research
ClinicalTrials.gov Identifier: NCT00821327
  Purpose

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.


Condition Intervention Phase
Urothelial Cancer
Drug: Gemcitabine, Cisplatin, Suntinib
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Sunitinib malate Sunitinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma

Further study details as provided by US Oncology Research:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To estimate the progression-free survival with gemcitabine, cisplatin, and sunitinib in patients To define the safety of combination therapy with gemcitabine, cisplatin, and sunitinib [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: August 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study Arm: Experimental
gemcitabine cisplatin sunitinib
Drug: Gemcitabine, Cisplatin, Suntinib
  1. Patients will receive gemcitabine 1000 mg/m2 IV (Days 1 and 8), cisplatin 70 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
  2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
  3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 thereafter.
  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 permitted)
  2. Has had major surgery or radiation therapy within 4 weeks of starting the study treatment
  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 therapy)
  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 care
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821327

Contacts
Contact: Mary A Rauch 832-348-5947 mary.rauch@usoncology.com

  Show 48 Study Locations
Sponsors and Collaborators
US Oncology Research
Pfizer
Investigators
Principal Investigator: Matthew D Galsky, MD US Oncology
Principal Investigator: Guru Spondave, MD US Oncology
  More Information

No publications provided

Responsible Party: US Oncology ( Matthew David Galsky, MD & Guru Spondave, MD )
Study ID Numbers: 06040
Study First Received: January 9, 2009
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00821327     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antimetabolites
Immunologic Factors
Radiation-Sensitizing Agents
Cisplatin
Sunitinib
Gemcitabine
Carcinoma, Transitional Cell
Angiogenesis Inhibitors
Immunosuppressive Agents
Antiviral Agents
Transitional Cell Carcinoma
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Cisplatin
Radiation-Sensitizing Agents
Sunitinib
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Gemcitabine

ClinicalTrials.gov processed this record on May 06, 2009