Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pfizer
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Dror Michaelson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00556049
First received: November 7, 2007
Last updated: January 8, 2014
Last verified: January 2014

November 7, 2007
January 8, 2014
December 2007
December 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00556049 on ClinicalTrials.gov Archive Site
  • To determine the time to tumor progression (TTP) of combination therapy with gemcitabine and sunitinib in this patient population. [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of this treatment in mRCC patients. [ Time Frame: Until disease progression ] [ Designated as safety issue: Yes ]
  • To determine the overall survival of this treatment in mRCC patients. [ Time Frame: Lifetime ] [ Designated as safety issue: No ]
  • To collect serum research samples for analysis of predictive biomarkers of response. [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma

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.

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Cell Carcinoma
  • Neoplasm Metastases
  • 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
Experimental: 1
Sunitinib and gemcitabine
Interventions:
  • Drug: Gemcitabine
  • Drug: Sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
December 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00556049
07-212
No
Dror Michaelson, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Pfizer
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
Principal Investigator: M. Dror Michaelson, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
January 2014

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