Pemetrexed Plus Gemcitabine in Renal Cell Cancer

Phase 2 Terminated 16 enrolled M.D. Anderson Cancer Center Eli Lilly and Company · collab

NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: * To determine the clinical activity of Pemetrexed + Gemcitabine in non-clear cell renal cell cancer (RCC). Clinical activity will take into account response rate and progression free survival (PFS). Secondary Objectives: * To determine the toxicity of Pemetrexed + Gemcitabine in non-clear cell RCC. * To estimate the survival rate of patients with non-clear cell RCC treated with this combination.

Timeline

Start: 2005-12
Primary completion: 2011-09
Completion: 2011-09

Outcome

Outcome not reported

Stopped (Enrollment): “Closed early for poor accrual.”

Publications

Background Richey SL, Tamboli P, Ng CS, Lin E, Lim ZD, Araujo JC, Jonasch E, Sharma P, Pagliaro LC, Tannir NM. Phase II trial of pemetrexed plus gemcitabine in patients with locally advanced and metastatic nonclear cell renal cell carcinoma. Am J Clin Oncol. 2013 Oct;36(5):450-4. doi: 10.1097/COC.0b013e3182546a91.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	1500 mg/m2	Intravenous
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous