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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT00885066
First received: April 18, 2009
Last updated: February 8, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: capecitabine
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • Clinical or laboratory toxicities as assessed by CTC [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gemcitabine, capecitabine, erlotinib Drug: capecitabine Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885066

Locations
France
Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Principal Investigator: Eric Francois Centre Antoine Lacassagne
  More Information

Additional Information:
No publications provided

Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT00885066     History of Changes
Other Study ID Numbers: CDR0000633338, CALACASS-CAPERGEM, ROCHE-CALACASS-CAPERGEM, INCA-RECF0622, EUDRACT-2007-005072-14
Study First Received: April 18, 2009
Last Updated: February 8, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Antoine Lacassagne:
stage III pancreatic cancer
stage IV pancreatic cancer
adenocarcinoma of the pancreas
recurrent pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Capecitabine
Erlotinib
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2015