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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

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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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