Spots Global Cancer Trial Database for A Safety, Tolerability and Efficacy Study of E7070 in Patients With Renal Cell Carcinoma

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Trial Identification

Brief Title: A Safety, Tolerability and Efficacy Study of E7070 in Patients With Renal Cell Carcinoma

Official Title: A Phase II Study of E7070 in Patients With Progressive Inoperable and/or Metastatic Renal Cell Carcinoma (RCC)

Study ID: NCT00059735

Conditions

Kidney Neoplasms

Carcinoma, Renal Cell

Adenocarcinoma, Renal Cell

Interventions

E7070

Study Description

Brief Summary: The purpose of this study is to determine if E7070 is a safe and effective treatment for cancer of the kidneys.

Detailed Description: Renal Cell Carcinoma (RCC) accounts for approximately 2% of all cancers and its incidence is increasing with worldwide deaths of over 100,000 patients per year. About 50% of RCC patients have inoperable or metastatic disease that surgery cannot be performed on. RCC is also considered to be resistant to both radiotherapy and cytotoxic chemotherapy. The purpose of this study is to evaluate the safety and effectiveness of E7070 by assessing progression free survival, tumor response rate, duration of response/stable disease, and survival time. E7070 will be administered as a single iv infusion over 60 minutes on Day 1 of each cycle. Patients will continue treatment with E7070 until they no longer have clinical benefit and have disease progression, or toxicity leads to patient withdrawal.