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Trial record 1 of 1 for:    NCT00556049
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Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00556049
Recruitment Status : Completed
First Posted : November 9, 2007
Results First Posted : April 3, 2015
Last Update Posted : April 21, 2016
Sponsor:
Collaborators:
Pfizer
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Dror Michaelson, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE November 7, 2007
First Posted Date  ICMJE November 9, 2007
Results First Submitted Date  ICMJE March 24, 2015
Results First Posted Date  ICMJE April 3, 2015
Last Update Posted Date April 21, 2016
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy. [ Time Frame: Until disease progression ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
  • To determine the time to tumor progression (TTP) of combination therapy with gemcitabine and sunitinib in this patient population. [ Time Frame: Until disease progression ]
  • To evaluate the safety and tolerability of this treatment in mRCC patients. [ Time Frame: Until disease progression ]
  • To determine the overall survival of this treatment in mRCC patients. [ Time Frame: Lifetime ]
  • To collect serum research samples for analysis of predictive biomarkers of response. [ Time Frame: Until disease progression ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
Official Title  ICMJE Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
Brief Summary The purpose of this research study is to determine if the combination of sunitinib and gemcitabine is effective in treating patients with metastatic renal cell carcinoma. The safety of this combination will also be studied. Sunitinib is approved by the FDA for the treatment of renal cell carcinoma. However, some patients' cancers do not respond to treatment or stops responding after initially responding. Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of pancreatic cancer and several other cancers. It is not approved for the treatment of renal cell carcinoma. Previous research has suggested that combining gemcitabine with sunitinib may have some effectiveness in treating metastatic renal cell carcinoma.
Detailed Description
  • Participants will receive study treatment as an outpatient. Study treatment will be given in 3-week cycles.
  • Sunitinib will be taken orally once per day for the first two weeks (days 1-14) of each treatment cycle.
  • Gemcitabine will be given intravenously at the study clinic on days 1 and 8 of each treatment cycle.
  • Before receiving sunitinib and gemcitabine on day 1 of each cycle the following will be performed: physical exam, performance status assessment and blood work. Before receiving gemcitabine on day 8 the following will be performed: physical exam, performance status assessment and blood work. Every 3 cycles a CT scan will be performed to measure the tumor.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Cell Carcinoma
  • Neoplasm Metastases
Intervention  ICMJE
  • Drug: Gemcitabine
    Intravenously on days 1 and 8 of each 21-day treatment cycle.
    Other Name: Gemzar
  • Drug: Sunitinib
    Orally on days 1-14 of each 21-day treatment cycle
    Other Name: Sutent
Study Arms  ICMJE Experimental: 1
Sunitinib and gemcitabine
Interventions:
  • Drug: Gemcitabine
  • Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2010)
72
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2007)
36
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven metastatic renal cell carcinoma with any sarcomatoid histology or poor-risk features as defined by having 3 or more of the following characteristics:

    • PS > 1, high serum lactate dehydrogenase
    • low hemoglobin
    • high "corrected" serum calcium
    • 2 or more sites of metastatic disease
    • time from initial diagnosis to evidence of metastatic disease 12 months or less
  • Evidence of unidimensional measurable disease based on RECIST criteria, with at least 1 measurable lesion
  • Male or female, 18 years of age or older
  • ECOG performance status of 0-2
  • Patients with brain metastasis can only be included of they were treated 4 weeks or more prior to enrollment with whole brain radiation and the effects of treatment have resolved
  • Resolution of all acute toxic effects of prior therapy, radiotherapy or surgical procedure to NCI CTCAE version 3.0 grade of 1 or less
  • Laboratory values as outlined in the protocol
  • 2 weeks or more must have elapsed from the time of major surgery or radiation therapy prior to the day of registration
  • No anticipated need for major surgical procedure during the course of the study

Exclusion Criteria:

  • Prior treatment with sunitinib or gemcitabine
  • More than one prior systemic therapy of any kind for renal cell carcinoma
  • Uncontrolled high blood pressure
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, or symptomatic congestive heart failure
  • Ejection fraction < 30%
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • NCT CTCAE grade 3 or higher hemorrhage within 4 weeks of starting treatment
  • Significant vascular disease
  • Current grade 3 or higher cardiac dysrhythmia or QT prolongation
  • Concurrent use of proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide
  • Pregnancy or breastfeeding or inadequate contraception
  • Evidence of bleeding diathesis or coagulopathy
  • Serious, non-healing wound, ulcer or bone fracture
  • Psychiatric illness/social situation that would limit compliance with study requirements
  • Previous diagnosis of concurrent malignancy requiring active systemic therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00556049
Other Study ID Numbers  ICMJE 07-212
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dror Michaelson, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • Pfizer
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
Investigators  ICMJE
Principal Investigator: M. Dror Michaelson, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP