NCT01411072

Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chemotherapy is given after curative surgery for pancreas cancer to try to improve cure rates. There are two choices of chemotherapy which are currently considered equal treatments: gemcitabine or 5-fluorouracil (5FU). This study is trying to determine if one of two standard chemotherapies is better than the other depending on whether patients have high or low human equilibrative nucleoside transporter 1 (hENT1). hENT1 is a protein that is found in varying amounts on pancreas cancers.

Detailed description

The rationale for this pilot study is based on trying to better deliver adjuvant chemotherapy by selecting treatment for patients that is individualized based on the hENT1 biomarker. Gemcitabine (gem) requires human equilibrative nucleoside transporter 1 (hENT1) to enter cells. If a pancreatic cancer has low hENT1, gem will not be able to enter cells efficiently. 5-fluorouracil (5FU) does not require the same transport into cells. Thus, upfront hENT1 testing will allow determination of therapy.

Conditions

• Pancreas Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine	Gem 1000 mg/m2 IV weekly for 3 weeks then one week off of each 28 day cycle
DRUG	5-fluorouracil	5-FU 425 mg/m2 and Leucovorin 20 mg/m2 IV day 1, 2, 3, 4, and 5 of each 28 day cycle

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2011-08-08
• Last updated: 2014-10-03

Locations

2 sites across 1 country: Canada