Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.

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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dong-A University Hospital, Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age older than 18
Younger than 75
ECOG performance status 0 or 1
Histologically confirmed adenocarcinoma of the pancreas
Metastatic pancreatic cancer
No prior chemotherapy for metastatic pancreatic cancer
A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)

Exclusion criteria

A patient with no measurable disease
A patient who received previous palliative chemotherapy for pancreatic cancer
A patient with locally advanced pancreatic cancer
A patient who received adjuvant chemotherapy for pancreatic cancer within 1 year
A patient with previous active or passive immunotherapy
A pregnant or lactating patient

Treatment and study plan

Gemcitabine, Cisplatin, Erlotinib (Tarceva)

Drug

Erlotinib 100 mg po q d daily AND
Gemcitabine 1000 mg/m² with 250 mL of normal saline intravenously infusion over 30 mins on Day 1, 8
Cisplatin 25 mg/m2 with 150 mL of normal saline intravenously infusion over 60 mins on D1,8

Every 3 weeks

Primary outcomes

To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer

Time frame: Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan

Sponsors and collaborators

Lead sponsor

Gyeongsang National University Hospital

Other

Collaborators

Chung-Ang University Hospital
Dong-A University Hospital

Registry information

Official study title

A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Jun 17, 2009
Registry last updated: Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed