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Gemzar, Cisp, Sunitinib Urothelial Ca
This study is ongoing, but not recruiting participants.

First Received on January 9, 2009.   Last Updated on June 6, 2011   History of Changes
Sponsor: US Oncology Research
Collaborator: 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma

Resource links provided by NLM:


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 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Arm
gemcitabine cisplatin sunitinib
Drug: Gemcitabine, Cisplatin, Suntinib

Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 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

  Show 48 Study Locations
Sponsors and Collaborators
US Oncology Research
Pfizer
Investigators
Principal Investigator: Guru Sonpavde, MD US Oncology
Principal Investigator: Thomas E Hutson, DO US Oncology
  More Information

No publications provided

Responsible Party: Guru Spondave, MD and Thomas Hutson, DO (Principal and Associate Investigators), US Oncology
ClinicalTrials.gov Identifier: NCT00821327     History of Changes
Other Study ID Numbers: 06040
Study First Received: January 9, 2009
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 09, 2012