OBJECTIVE: To determine the clinical activity and safety of the combination of pemetrexed and gemcitabine in advanced nonclear cell renal cell carcinoma (nccRCC). METHODS: In this phase II study, patients received pemetrexed 500 mg/m intravenous infusion over 10 minutes on day 1 followed immediately by gemcitabine 1500 mg/m intravenously over 30 minutes on day 1, with cycles repeated every 14 days. Planned enrollment was 40 patients. The primary endpoints were objective response rate and progression-free survival (PFS). The secondary endpoints were safety and overall survival. RESULTS: Between December 2005 and December 2008, 16 patients with locally advanced or metastatic nccRCC were enrolled. The trial was stopped early due to low efficacy and excessive toxicity. The objective response rate was 0% [95% confidence interval (CI), 0%-18%]. The median number of cycles administered was 4 (range, 1 to 12). Median PFS was 3.2 months (95% CI, 1.9-6+), and the 16-week PFS rate was 46.7% (95% CI, 19.8%-100%). Median overall survival was 23.2 months (95% CI, 12.9-38.1). The most common grade 3 or 4 adverse events were neutropenia (53%), leukopenia (53%), anemia (13%), fatigue (40%), and renal insufficiency (13%). CONCLUSIONS: In this phase II trial in nccRCC, the combination of pemetrexed and gemcitabine was toxic and ineffective. Further development of this regimen in nccRCC is not warranted.
OBJECTIVE: To determine the clinical activity and safety of the combination of pemetrexed and gemcitabine in advanced nonclear cell renal cell carcinoma (nccRCC). METHODS: In this phase II study, patients received pemetrexed 500 mg/m intravenous infusion over 10 minutes on day 1 followed immediately by gemcitabine 1500 mg/m intravenously over 30 minutes on day 1, with cycles repeated every 14 days. Planned enrollment was 40 patients. The primary endpoints were objective response rate and progression-free survival (PFS). The secondary endpoints were safety and overall survival. RESULTS: Between December 2005 and December 2008, 16 patients with locally advanced or metastatic nccRCC were enrolled. The trial was stopped early due to low efficacy and excessive toxicity. The objective response rate was 0% [95% confidence interval (CI), 0%-18%]. The median number of cycles administered was 4 (range, 1 to 12). Median PFS was 3.2 months (95% CI, 1.9-6+), and the 16-week PFS rate was 46.7% (95% CI, 19.8%-100%). Median overall survival was 23.2 months (95% CI, 12.9-38.1). The most common grade 3 or 4 adverse events were neutropenia (53%), leukopenia (53%), anemia (13%), fatigue (40%), and renal insufficiency (13%). CONCLUSIONS: In this phase II trial in nccRCC, the combination of pemetrexed and gemcitabine was toxic and ineffective. Further development of this regimen in nccRCC is not warranted.
Authors: H von der Maase; J Lehmann; G Gravis; H Joensuu; P F Geertsen; J Gough; G Chen; M Kania Journal: Ann Oncol Date: 2006-07-27 Impact factor: 32.976
Authors: H Oettle; D Richards; R K Ramanathan; J L van Laethem; M Peeters; M Fuchs; A Zimmermann; W John; D Von Hoff; M Arning; H L Kindler Journal: Ann Oncol Date: 2005-08-08 Impact factor: 32.976
Authors: Bernard Escudier; Tim Eisen; Walter M Stadler; Cezary Szczylik; Stéphane Oudard; Michael Siebels; Sylvie Negrier; Christine Chevreau; Ewa Solska; Apurva A Desai; Frédéric Rolland; Tomasz Demkow; Thomas E Hutson; Martin Gore; Scott Freeman; Brian Schwartz; Minghua Shan; Ronit Simantov; Ronald M Bukowski Journal: N Engl J Med Date: 2007-01-11 Impact factor: 91.245
Authors: Toni K Choueiri; Anne Plantade; Paul Elson; Sylvie Negrier; Alain Ravaud; Stephane Oudard; Ming Zhou; Brian I Rini; Ronald M Bukowski; Bernard Escudier Journal: J Clin Oncol Date: 2008-01-01 Impact factor: 44.544
Authors: Giorgio Vittorio Scagliotti; Purvish Parikh; Joachim von Pawel; Bonne Biesma; Johan Vansteenkiste; Christian Manegold; Piotr Serwatowski; Ulrich Gatzemeier; Raghunadharao Digumarti; Mauro Zukin; Jin S Lee; Anders Mellemgaard; Keunchil Park; Shehkar Patil; Janusz Rolski; Tuncay Goksel; Filippo de Marinis; Lorinda Simms; Katherine P Sugarman; David Gandara Journal: J Clin Oncol Date: 2008-05-27 Impact factor: 44.544
Authors: Nizar M Tannir; Peter F Thall; Chaan S Ng; Xuemei Wang; Leiko Wooten; Arlene Siefker-Radtke; Paul Mathew; Lance Pagliaro; Christopher Wood; Eric Jonasch Journal: J Urol Date: 2008-07-17 Impact factor: 7.450
Authors: Gary Hudes; Michael Carducci; Piotr Tomczak; Janice Dutcher; Robert Figlin; Anil Kapoor; Elzbieta Staroslawska; Jeffrey Sosman; David McDermott; István Bodrogi; Zoran Kovacevic; Vladimir Lesovoy; Ingo G H Schmidt-Wolf; Olga Barbarash; Erhan Gokmen; Timothy O'Toole; Stephanie Lustgarten; Laurence Moore; Robert J Motzer Journal: N Engl J Med Date: 2007-05-31 Impact factor: 91.245
Authors: Robert J Motzer; Bernard Escudier; Stéphane Oudard; Thomas E Hutson; Camillo Porta; Sergio Bracarda; Viktor Grünwald; John A Thompson; Robert A Figlin; Norbert Hollaender; Gladys Urbanowitz; William J Berg; Andrea Kay; David Lebwohl; Alain Ravaud Journal: Lancet Date: 2008-07-22 Impact factor: 79.321