Trial Search Results

Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery

The purpose of this trial is to study giving sunitinib malate together with or without gemcitabine hydrochloride to see how well they work in treating patients with advanced kidney cancer that cannot be removed by surgery. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):


  • Drug: gemcitabine hydrochloride
  • Drug: sunitinib malate


Phase 2



   - Histologically confirmed* renal cell carcinoma

      - Disease of any subtype allowed

      - Disease must have sarcomatoid features NOTE: *Patients must have a
      paraffin-embedded tumor specimen from the kidney or metastatic site available for
      central review and confirmation of tumor histology

   - No collecting duct or medullary carcinoma

   - Measurable advanced disease that is not resectable by surgery

   - Patients with resected or radiated brain metastases or those treated with stereotactic
   radiation therapy are eligible, provided they have been off steroids for at least 2


   - ECOG performance status 0-2

   - AGC ≥ 1,500/mm^3

   - Platelet count ≥ 100,000/mm^3

   - Hemoglobin ≥ 9.0 g/dL (transfusions allowed)

   - Serum creatinine clearance ≥ 30 mL/min

   - SGOT and SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)

   - Total bilirubin ≤ 1.5 times ULN

   - Baseline QTc interval < 500 msec on EKG

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception before and during study treatment

   - Able to swallow pills

   - No history of stroke within the past 6 months

   - No clinically significant cardiovascular disease, defined as one of the following:

      - Uncontrolled hypertension (BP > 150/100 mm Hg at the time of enrollment)

         - Patients with hypertension and BP ≤ 150/100 mm Hg on stable antihypertensive
         regimen are eligible

      - History of myocardial infarction or unstable angina within the past 24 weeks

      - NYHA class II-IV congestive heart failure, serious cardiac arrhythmia requiring
      medication, or unstable angina pectoris

      - Peripheral vascular disease ≥ grade II

   - No ongoing ventricular cardiac dysrhythmias ≥ grade 2 as assessed by NCI CTCAE version

      - No patients with a history of serious ventricular arrhythmia (ventricular
      tachycardia or ventricular fibrillation > 3 beats in a row)

      - No patients with ongoing atrial fibrillation

   - No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be
   maintained at less than or within the normal range with medication

   - No serious concurrent illness or active infection that would jeopardize the ability of
   the patient to receive study treatment

   - No known HIV

   - Patients with a history of prior malignancy are eligible provided they were treated
   with curative intent and have been disease free for the time period considered
   appropriate to not interfere with the outcome of this study


   - No prior systemic therapy for metastatic disease

      - Patients who were randomized to placebo on an adjuvant study are eligible

   - More than 2 weeks since prior radiotherapy and recovered

      - Previously irradiated lesions must not be the sole site of disease

   - More than 2 weeks since prior and no concurrent ketoconazole, dexamethasone,
   dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil,
   indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or
   grapefruit juice

      - Topical and inhaled steroids are allowed

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting