Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
cetuximab
fluorouracil
irinotecan hydrochloride
leucovorin calcium
pharmacological study
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, recurrent colon cancer, stage IV rectal cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
- Advanced or metastatic disease
- Scheduled to receive first- or second-line therapy for metastatic disease
- No cerebral metastases or symptomatic or uncontrolled meningeal disease
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 2 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No intestinal blockage
- No complete dihydropyrimidine dehydrogenase deficiency
- No chronic inflammatory disease of the colon
- No other cancer except for nonmelanoma skin cancer or curatively treated carcinoma of the cervix or breast
No other severe condition, or condition that is likely to worsen, including any of the following:
- Unstable heart disease
- Myocardial infarction within the past 6 months
- Active uncontrolled infection
- No contraindication to atropine
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior anticancer therapy
- More than 4 weeks since prior and no other concurrent investigational therapy
- Prior adjuvant chemotherapy allowed
- No prior fluorouracil or irinotecan hydrochloride
- No other concurrent anticancer therapy
Sites / Locations
- Centre Paul Papin
Outcomes
Primary Outcome Measures
Improvement of hematologic and gastrointestinal tolerance to therapy
Secondary Outcome Measures
Efficacy
Genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of therapy
Time to progression
Full Information
NCT ID
NCT00559741
First Posted
November 15, 2007
Last Updated
May 12, 2011
Sponsor
Institut Cancerologie de l'Ouest
1. Study Identification
Unique Protocol Identification Number
NCT00559741
Brief Title
Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
Official Title
Phase 2 Study to Improve Tolerance of Chemotherapy Involving Cetuximab and Multidrug FOLFIRI, With Pharmacokinetic and Pharmacogenetic Studies, in Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Institut Cancerologie de l'Ouest
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works in treating patients with advanced or metastatic colorectal cancer.
Detailed Description
OBJECTIVES:
Primary
Improve hematologic and gastrointestinal tolerance to cetuximab and irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) in patients with advanced or metastatic colorectal cancer.
Secondary
Increase the effectiveness of this regimen by intensifying the treatment.
Specify the constitutional genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of this regimen.
Assess the time to progression.
OUTLINE: This is a multicenter study.
Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and cetuximab IV over 1-2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Pharmacokinetic and pharmacogenetic studies are also conducted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, recurrent colon cancer, stage IV rectal cancer, recurrent rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
cetuximab
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Other
Intervention Name(s)
pharmacological study
Primary Outcome Measure Information:
Title
Improvement of hematologic and gastrointestinal tolerance to therapy
Secondary Outcome Measure Information:
Title
Efficacy
Title
Genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of therapy
Title
Time to progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
Advanced or metastatic disease
Scheduled to receive first- or second-line therapy for metastatic disease
No cerebral metastases or symptomatic or uncontrolled meningeal disease
PATIENT CHARACTERISTICS:
WHO performance status 0-2
ANC ≥ 2,000/mm^3
Platelet count ≥ 100,000/mm^3
Total bilirubin ≤ 2 times upper limit of normal (ULN)
AST and ALT ≤ 3 times ULN
Alkaline phosphatase ≤ 5 times ULN
Not pregnant or nursing
Fertile patients must use effective contraception
No intestinal blockage
No complete dihydropyrimidine dehydrogenase deficiency
No chronic inflammatory disease of the colon
No other cancer except for nonmelanoma skin cancer or curatively treated carcinoma of the cervix or breast
No other severe condition, or condition that is likely to worsen, including any of the following:
Unstable heart disease
Myocardial infarction within the past 6 months
Active uncontrolled infection
No contraindication to atropine
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Recovered from prior anticancer therapy
More than 4 weeks since prior and no other concurrent investigational therapy
Prior adjuvant chemotherapy allowed
No prior fluorouracil or irinotecan hydrochloride
No other concurrent anticancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erick Gamelin, MD
Organizational Affiliation
Institut Cancerologie de l'Ouest
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
18797458
Citation
Rouits E, Charasson V, Petain A, Boisdron-Celle M, Delord JP, Fonck M, Laurand A, Poirier AL, Morel A, Chatelut E, Robert J, Gamelin E. Pharmacokinetic and pharmacogenetic determinants of the activity and toxicity of irinotecan in metastatic colorectal cancer patients. Br J Cancer. 2008 Oct 21;99(8):1239-45. doi: 10.1038/sj.bjc.6604673. Epub 2008 Sep 16.
Results Reference
result
PubMed Identifier
26615857
Citation
Rollin J, Payance A, Gouilleux-Gruart V, Boisdron-Celle M, Azzopardi N, Morel A, Gruel Y, Paintaud G, Gamelin E, Watier H, Lecomte T. Significant effect of VEGFA polymorphisms on the clinical outcome of metastatic colorectal cancer patients treated with FOLFIRI-cetuximab. Pharmacogenomics. 2015 Dec;16(18):2035-43. doi: 10.2217/pgs.15.139. Epub 2015 Nov 30.
Results Reference
derived
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Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
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