Clinical Trial ECOG 1808
- A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features
- Principal Investigator
- Timothy Kuzel
- Status: Accepting New Patients
- 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
Find Related Clinical Trials
Browse by Disease Sites
Other Clinical Trials by Timothy Kuzel
- Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma
- Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma
- A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects with Metastatic or Unresectable Melanoma in Combination with Dabrafenib and Trametinib or with Trametinib Alone
- A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy
- A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas
- Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy
- A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-a in Advanced Melanoma
- A Randomized Phase II Study of Sequential Biotherapy with Aflibercept and High Dose IL-2 versus High Dose IL-2 alone in Patients with Inoperable Stage III or Stage IV Melanoma: Efficacy and Biomarker Study
- A Randomized Phase I Dose-Escalation Trial of Carfilzomib with and without Romidepsin in Cutaneous T-Cell Lymphoma
- Phase II Trial of Everolimus or Everolimus plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma (GU10-147)
last updated: 30-Aug-15 04:52 AM
Clinical trial availability changes frequently. Please check this site often for updates or call 312.695.1102 for personal assistance.