Clinical Trial ECOG 1808
- A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features
- Principal Investigator
- Benedito Carneiro
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.ECOG 1808
- The purpose of this study is to find out what effects, good and/or bad, sunitinib alone or the chemotherapy combination of sunitinib and gemcitabine has on advanced kidney cancer with sarcomatoid features.
- The use of sunitinib alone is approved for the use in advanced renal cell cancer, but using sunitinib and gemcitabine together is investigational and has not been approved by the Food and Drug Administration (FDA) for use in this type of cancer. Gemcitabine has been used for renal cell cancer in the past and is commercially available. It is also approved for pancreatic cancer.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Patients must have renal cell carcinoma (of any subtype) containing any sarcomatoid features.
- Participants must not have had radiation therapy less than 2 weeks prior to randomization and participants must be recovered from any toxicities associated with radiation therapy.
- Description of Treatment
- Participants will be "randomized" into one of the study groups, "arm A" or "arm B". Randomization means that participants will be put into a group by chance. Participants in arm A will receive gemcitabine by vein over 30 minutes on days 1, 8, 22 and 29 of every treatment cycle. A treatment cycle is 42 days. Participants will also receive sunitinib by mouth on days 1 through 14 and days 22 through 35 of each treatment cycle. Participants will have a break from treatment on days 15-21 and days 36-42 of each cycle. Participants in arm B will receive sunitinib by mouth on days 1 through 14 and days 22 through 35 of each treatment cycle. A treatment cycle is 42 days. Participants will have a break from treatment on days 15-21 and days 36-42 of each cycle. Participants in both arms will receive treatment for about a year total, as long as the cancer is responding to treatment and there are no serious side effects.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 01-Oct-16 05:23 AM
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