Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer

NCT00559741 | Completed Phase 2

• 3 other identifiers: CDR0000574065CPP-FOLFIRICETUXINCA-RECF0108
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; recurrent colon cancer; stage IV rectal cancer; recurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

• Improvement of hematologic and gastrointestinal tolerance to therapy

Secondary Outcomes (3)

• Efficacy

• Genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of therapy

• Time to progression

Interventions

cetuximab BIOLOGICAL

fluorouracil DRUG

irinotecan hydrochloride DRUG

leucovorin calcium DRUG

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Centre Paul Papin

Angers, 49036, France

Location

Related Publications (3)

• 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.

  PMID: 18797458 RESULT

• Lobet S, Paintaud G, Azzopardi N, Passot C, Caulet M, Chautard R, Desvignes C, Capitain O, Tougeron D, Lecomte T, Ternant D. Relationship Between Cetuximab Target-Mediated Pharmacokinetics and Progression-Free Survival in Metastatic Colorectal Cancer Patients. Clin Pharmacokinet. 2023 Sep;62(9):1263-1274. doi: 10.1007/s40262-023-01270-2. Epub 2023 Jul 13.

  PMID: 37442917 DERIVED

• 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.

  PMID: 26615857 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Cetuximab; Fluorouracil; Irinotecan; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Erick Gamelin, MD

  Institut Cancerologie de l'Ouest

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: October 1, 2005
• Primary Completion: May 1, 2011
• Last Updated: May 13, 2011

Record last verified: 2011-05

Locations

FR (1)