Gemcitabine, Capecitabine, And Erlotinib In Treating Patients With Advanced Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer

DRUG: capecitabine
DRUG: erlotinib hydrochloride
DRUG: gemcitabine hydrochloride

CDR0000633338
CALACASS-CAPERGEM
ROCHE-CALACASS-CAPERGEM
INCA-RECF0622
EUDRACT-2007-005072-14

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-04-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-02-08
First Submitted that Met QC Criteria 2009-04-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-02-10
First Posted (ESTIMATED) 2009-04-21	Results First Posted N/A	Last Verified 2015-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: gemcitabine, capecitabine, erlotinib	DRUG: capecitabine DRUG: erlotinib hydrochloride DRUG: gemcitabine hydrochloride

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: gemcitabine, capecitabine, erlotinib

DRUG: capecitabine

DRUG: erlotinib hydrochloride

DRUG: gemcitabine hydrochloride

Primary Outcome Measures	Measure Description	Time Frame
Clinical or laboratory toxicities as assessed by CTC		1 year

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Eric Francois, Centre Antoine Lacassagne

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record