Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer

Phase 1 Terminated 12 enrolled University of Alabama at Birmingham GlaxoSmithKline · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the maximum tolerated dose of Lapatinib with Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with carboplatin AUC 6 in this cohort of patients.

Timeline

Start: 2005-11
Primary completion: 2007-03
Completion: 2007-04

Outcome

Outcome not reported

Stopped: “Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.”

Publications

Results Kimball KJ, Numnum TM, Kirby TO, Zamboni WC, Estes JM, Barnes MN, Matei DE, Koch KM, Alvarez RD. A phase I study of lapatinib in combination with carboplatin in women with platinum sensitive recurrent ovarian carcinoma. Gynecol Oncol. 2008 Oct;111(1):95-101. doi: 10.1016/j.ygyno.2008.07.001. Epub 2008 Aug 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lapatinib	Small molecule	750 mg	Oral