Application of Aprepitant as salvage prophylaxis after failure of a conventional antiemetic therapy during moderately emetogenic chemotherapy in gastrointestinal cancer - EMEND_GI

• Conditions: Chemotherapy-induced nasuea and vomiting (CINV)

• Registration Number: EUCTR2004-003783-30-DE
• Lead Sponsor: Technical Unversity of Munich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Treatment of any tumor in the gastrointestinal tract with moderately emetogenic chemotherapy.
Failure of a adequate standard prophylaxis

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Treatment of any tumor in the gastrointestinal tract with delayed CINV after day 5.

Past treatment with CINV >/= degree 2.

Known incompatibility compared to study medication.

Failure competency of the patient as to protocol instruction.

Patients with childbearing potential or lactation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessment of the protection from by acute and delayed nausea an emesis on days 1-5 of a moderately emetogenic chemotherapy cycle.<br>Partial response is defined as: decrease of the severity ofnausea and emesis of at least one grade according to the NCI.CTC classification.<br>;Secondary Objective: Assessment of protection from acute nausea and emesis on day 1.<br>Assessment of protection from delayed nausea and emesis on days 2-5.<br>Safety and efficacy for higher dosages of aprepitant.<br>Assessment of potential risk factor for CINV.<br>Assessment of adverse effects.<br>Incidence of nausea and emesis.<br>Pharmacoeconomic analysis.<br>;Primary end point(s): Assessment of the protection from by acute and delayed nausea an emesis on days 1-5 of a moderately emetogenic chemotherapy cycle.<br>Partial response is defined as: decrease of the severity ofnausea and emesis of at least one grade according to the NCI.CTC classification.<br>