Capecitabine, Carboplatin and Weekly Paclitaxel for Patients With Solid Tumors and Adenocarcinoma of Unknown Primary

NCT00201734 ↗

Phase 1/2 Terminated 57 enrolled Ohio State University Comprehensive Cancer Center Roche Pharma AG · collab

NaSingle-groupOpen-labelTreatment

Summary

This study will determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks with carboplatin.

Timeline

Start: 2005-06
Primary completion: 2007-11
Completion: 2013-06

Outcome

Outcome not reported

Stopped (Business): “Due to lack of funding provided for Phase II portion of trial”

Publications

Background Mikhail S, Lustberg MB, Ruppert AS, Mortazavi A, Monk P, Kleiber B, Villalona-Calero M, Bekaii-Saab T. Biomodulation of capecitabine by paclitaxel and carboplatin in advanced solid tumors and adenocarcinoma of unknown primary. Cancer Chemother Pharmacol. 2015 Nov;76(5):1005-12. doi: 10.1007/s00280-015-2877-6. Epub 2015 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	500 mg/m2	Oral
Subject	Capecitabine	Small molecule	750 mg/m2	Oral
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Paclitaxel	Small molecule	60 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Background	Carboplatin	Small molecule	6 unknown	Intravenous