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

April 18, 2009
December 23, 2009
May 2008
March 2010   (final data collection date for primary outcome measure)
Clinical or laboratory toxicities as assessed by CTC [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00885066 on ClinicalTrials.gov Archive Site
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Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers

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.

Interventional
Phase 1
Allocation: Non-Randomized
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: capecitabine
  • Drug: erlotinib hydrochloride
  • Drug: gemcitabine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
France
 
NCT00885066
CDR0000633338, CALACASS-CAPERGEM, ROCHE-CALACASS-CAPERGEM, INCA-RECF0622, EUDRACT-2007-005072-14
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Centre Antoine Lacassagne
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Principal Investigator: Eric Francois Centre Antoine Lacassagne
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP