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

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