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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Neoplasm Metastases Drug: Gemcitabine Drug: Sunitinib Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
Study Start Date : December 2007
Primary Completion Date : December 2013
Study Completion Date : December 2014

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Sunitinib and gemcitabine
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556049

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center`
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Principal Investigator: M. Dror Michaelson, MD, PhD Massachusetts General Hospital
More Information

Responsible Party: Dror Michaelson, MD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00556049     History of Changes
Other Study ID Numbers: 07-212
First Posted: November 9, 2007    Key Record Dates
Results First Posted: April 3, 2015
Last Update Posted: April 21, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dror Michaelson, MD, Massachusetts General Hospital:

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances