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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00885066
First received: April 18, 2009
Last updated: December 23, 2009
Last verified: July 2009
  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
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 National Cancer Institute (NCI):

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

Estimated Enrollment: 30
Study Start Date: May 2008
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885066

Locations
France
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Eric Francois    33-04-9203-1114      
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Principal Investigator: Eric Francois Centre Antoine Lacassagne
  More Information

Additional Information:
No publications provided

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: December 23, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III pancreatic cancer
stage IV pancreatic cancer
adenocarcinoma of the pancreas
recurrent pancreatic cancer

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

ClinicalTrials.gov processed this record on April 22, 2014