Back to resultsGemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
capecitabine
erlotinib hydrochloride
gemcitabine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer
Eligibility 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
Sites / Locations
- Centre Antoine Lacassagne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gemcitabine, capecitabine, erlotinib
Arm Description
Outcomes
Primary Outcome Measures
Clinical or laboratory toxicities as assessed by CTC
Secondary Outcome Measures
Full Information
NCT ID
NCT00885066
First Posted
April 18, 2009
Last Updated
February 8, 2015
Sponsor
Centre Antoine Lacassagne
1. Study Identification
Unique Protocol Identification Number
NCT00885066
Brief Title
Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
Official Title
Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gemcitabine, capecitabine, erlotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Primary Outcome Measure Information:
Title
Clinical or laboratory toxicities as assessed by CTC
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Francois
Organizational Affiliation
Centre Antoine Lacassagne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
12. IPD Sharing Statement
Learn more about this trial
Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
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