Trial Outcomes & Findings for Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary (NCT NCT00066781)

Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary

The primary endpoint is confirmed response rate. If measurable disease is present, a confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. All registered patients meeting the eligibility criteria that have signed a consent form and have begun treatment will be evaluable for response.

Overall survival time is defined as the time from registration to death due\> to any cause. The distribution of survival time will be estimated using\> the method of Kaplan-Meier . Overall survival will be calculated for\> all evaluable patients combined and by group (ie. for patients with or\> without the UGT1A1\*28 polymorphism).

Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Time to disease progression will be calculated for all evaluable patients combined and by group (ie. for patients with or without the UGT1A1\*28 polymorphism).