drugset / Trial / NCT00881621

Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

NCT00881621 ↗

Phase 2 Terminated 17 enrolled Georgetown University GlaxoSmithKline · collab
NaSingle-groupOpen-labelTreatment

Summary

Patients are being asked to participate in this study who have locally advanced or metastatic pancreatic cancer (cancer of the pancreas that has spread to another part of the body) that has gotten worse after first-line chemotherapy. The purpose of this study is to see if the drugs, Capecitabine and Lapatinib (two chemotherapy agents), prolong survival and improve quality of life as compared to supportive care alone. Lapatinib in combination with a drug called capecitabine, has been approved by the Food and Drug Administration (FDA) for the treatment of metastatic breast cancer. It has not yet been approved to treat this type of cancer. Both of these drugs are pills. This research is being done because it is not known if the combination of Capecitabine and Lapatinib is better than supportive care alone for pancreatic cancer.

Timeline

Start
2009-08
Primary completion
2012-12
Completion
2013-06

Outcome

Outcome not reported

Stopped (Enrollment): “slow enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Lapatinib Small molecule 1250 mg Oral