Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

Metastatic Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922896
• Other study ID #: Gyeongsang-001
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2009
• Last updated: November 18, 2012
• Start date: June 2009
• Est. completion date: May 2011

Study information

• Verified date: November 2012
• Source: Gyeongsang National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine, Cisplatin, Erlotinib (Tarceva)
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

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Gyeongsang Unversity Hospital	JinJU
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Gyeongsang National University Hospital	Chung-Ang University Hospital, Dong-A University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer		Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan	Yes