drugset

drugset / Trial / NCT00201747

Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer

NCT00201747 ↗

Phase 2 Completed 80 enrolled Ohio State University Comprehensive Cancer Center Pharmacia and Upjohn · collab

NaSingle-groupOpen-labelTreatment

Summary

To determine the most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas.

Timeline

Start: 2001-09
Primary completion: 2006-10
Completion: 2010-02

Publications

Results Lustberg MB, Bekaii-Saab T, Young D, Otterson G, Burak W, Abbas A, McCracken-Bussa B, Lustberg ME, Villalona-Calero MA. Phase II randomized study of two regimens of sequentially administered mitomycin C and irinotecan in patients with unresectable esophageal and gastroesophageal adenocarcinoma. J Thorac Oncol. 2010 May;5(5):713-8. doi: 10.1097/JTO.0b013e3181d7776d.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	125 mg/m2	Intravenous
Subject	Mitomycin C	Other / unclassified	3 mg/m2	Intravenous
Subject	Mitomycin C	Other / unclassified	6 mg/m2	Intravenous

Indications