Phase II study of XXXX in recurrent or metastatic @entity213 : GORTEC 2006-01.

@entity1 @entity135 @entity137 @entity66 @entity2240 @entity5 @entity74 @entity213
PURPOSE To assess the efficacy and @entity137 of @entity2240 monotherapy in palliative @entity213 ( @entity213 ). @entity1 AND METHODS Thirty-eight @entity1 with @entity213 having evidence of @entity74 ( @entity74 ) were treated with @entity2240 37.5 mg/d given continuously until @entity74 or unacceptable @entity137 . The primary end point was the rate of disease control, defined as @entity66 ( @entity66 ) or partial response (PR) at 6 to 8 weeks after treatment initiation (two-stage design, Simon). Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) was performed in a subset of @entity1 before and 6 to 8 weeks after treatment. The volume transfer constant of the contrast agent (K(trans)) was used to measure changes in the microcirculation blood flow and endothelial permeability of the @entity5 . Results A PR was observed in one @entity1 , @entity66 in 18, and @entity74 in 19 (Response Evaluation Criteria in Solid Tumors [RECIST]), resulting in a disease control rate of 50%. Among the 18 @entity1 with @entity66 , there were five unconfirmed PRs and six additional minor responses. A significant decrease in K(trans) was seen in three of the four @entity1 who received DCE-MRI monitoring. Grade 5 @entity135 occurred in four @entity1 . Local complications, including the appearance or worsening of @entity5 skin ulceration or @entity5 fistula, were recorded in 15 @entity1 . CONCLUSION @entity2240 demonstrated modest activity in palliative SSCHN. The severity of some of the complications highlights the importance of improved @entity1 selection for future studies with @entity2240 in @entity135 . @entity2240 should not be used outside clinical trials in SSCHN.
