Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885066
• Other study ID #: CDR0000633338
• Secondary ID: CALACASS-CAPERGE
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2009
• Last updated: February 8, 2015
• Start date: May 2008
• Est. completion date: October 2009

Study information

• Verified date: February 2015
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.

Description:

OBJECTIVES:

Primary

• Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.

Secondary

• Analyze the limiting toxicities according to CTC.

• Analyze the toxicity according to CTC.

• Determine the recommended dose.

• Determine the pharmacokinetic dosages of the three drugs.

• Analyze interactions between the drugs.

OUTLINE: This is a multicenter study.

Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• Advanced disease

• No standard curative therapy available

• Must have received prior first-line chemotherapy

• No brain metastasis

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Life expectancy = 8 weeks

• ANC = 1.5 x 10^9/ L

• Platelet count = 130 x 10^9/ L

• Hemoglobin = 10 g/dL

• Liver transaminases = 1.5 times upper limit of normal (ULN) (= 5 times ULN in the presence of liver metastases)

• Bilirubin = 1.5 times ULN

• Creatinine = 130 mmol/L OR creatinine clearance > 30 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No intolerance or hypersensitivity to any of the drugs being tested

• No history of interstitial lung disease

• No history of severe cardiac disease

• No serious uncontrolled infection

• No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome

• Must not be deprived of liberty or under guardianship

• Must not be on probation

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior erlotinib hydrochloride

• No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4

• More than 14 days since participation in another clinical trial

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• capecitabine

• erlotinib hydrochloride

• gemcitabine hydrochloride

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical or laboratory toxicities as assessed by CTC		1 year	Yes