Phase II Trial of Pemetrexed Plus Gemcitabine in Patients With Locally Advanced and Metastatic Nonclear Cell Renal Cell Carcinoma

Abstract

OBJECTIVE To determine the clinical activity and toxicity of combination pemetrexed and gemcitabine for locally advance and metastatic non-clear cell renal cell carcinoma. METHODS In this phase II study patients were treated with pemetrexed 500 mg/m2 IV infusion over 10 minutes(min) on day one followed immediately by gemcitabine 1500 mg/m2 IV over 30 min on day one, repeated every fourteen days. Planned enrollment was 40 patients. The primary endpoints were response rate and progression free survival (PFS). The secondary endpoints were toxicity and overall survival (OS) in months (mo). RESULTS Between December 2005 and December 2008, 16 patients with locally advanced or metastatic non clear cell renal cell carcinoma were enrolled. The trial was stopped due to lack of response and excessive toxicity. The overall response rate was 6.7% (95% exact CI: 0.2%–31.9%), no patients with renal cell carcinoma responded to therapy. The median number of cycles administered was 4 (range: 1–12 cycles), median PFS was 3.2 mo (95% CI: 1.875–>6 mo), and the 16-week PFS rate was 46.7% (95% CI: 19.8%–100%). The median OS was 23.2 mo (95% CI: 12.9–38.1 mo). The most common grade 3 or 4 toxicities were neutropenia (53%), leukopenia (53%), anemia (13%), fatigue (40%), and renal failure (13%). CONCLUSIONS Patients with non clear cell carcinoma metastatic renal cell carcinoma. The combination of pemetrexed and gemcitabine did not show clinical activity in this cohort of patients with non clear cell renal cell carcinoma.

Chemotherapy in metastatic renal cell carcinoma today? A systematic review

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Synergistic immunotherapeutic effects of Lycium barbarum polysaccharide and interferon-α2b on the murine Renca renal cell carcinoma cell line in vitro and in vivo

“…Renal cell carcinoma (RCC), which accounts for ~3% of all malignancies, is one of the most lethal urologic malignancies ( 1 ) and 20–30% of all patients are diagnosed with metastatic disease ( 2 ). Systemic therapeutic strategies for advanced RCC include surgical management, chemotherapy, radiotherapy, immunotherapy and molecular targeted therapy ( 3 – 5 ). Following nephrectomy, 20% of patients will suffer a relapse and develop metastatic (m)RCC ( 6 ).…”

Management of non–clear cell renal cell carcinoma: Current approaches

“…There was no response to treatment in 16 patients with papillary RCC, so the study was terminated prematurely. Pemetrexed and gemcitabine combination was studied in patients with locally advanced or metastatic nCCRCC [56]. Only 16 patients were enrolled, but no more owing to the inadequate combination of the response rate (6.7%).…”