Evaluating Panitumumab (ABX-EGF) in Patients With Metastatic Colorectal Cancer

NCT00111761 | Completed Phase 2 Results DMC

• 1 other identifier: 20025409
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if panitumumab, in combination with irinotecan, leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

Immunex; Panitumumab; ABX-EGF; Abgenix

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2)

  The number of participants with grade 3 or grade 4 diarrhea in Part 2 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).

  Until disease progression (median 47 weeks)

• Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 1)

  The number of participants with grade 3 or grade 4 diarrhea in Part 1 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).

  Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first

Secondary Outcomes (11)

• Number of Participants With an Objective Tumor Response (Part 2)

  Until disease progression (median 47 weeks)

• Time to Disease Progression (Part 2)

  From enrollment until death or diease progression. Maximum follow-up time was 16 months.

• Progression-free Survival Time (Part 2)

  From enrollment until disease progression or death. Maximum follow-up time was 16 months.

• Survival Time (Part 2)

  From enrollment until death. Maximum follow-up time was 16 months.

• Number of Participants Who Died (Part 2)

  From enrollment until last contact. Maximum follow-up was 16 months.

Study Arms (2)

Part 1: Panitumumab + IFL

EXPERIMENTAL

Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil (5-FU)and leucovorin (IFL chemotherapy regimen)

Drug: Irinotecan; Biological: Panitumumab; Drug: 5-Fluorouracil; Drug: Leucovorin

Part 2: Panitumumab + FOLFIRI

EXPERIMENTAL

Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)

Drug: Irinotecan; Biological: Panitumumab; Drug: 5-Fluorouracil; Drug: Leucovorin

Interventions

Irinotecan DRUG

Part 1: 125 mg/m\^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m\^2 IV infusion every other week until disease progression or unable to tolerate.

Part 1: Panitumumab + IFL; Part 2: Panitumumab + FOLFIRI

Panitumumab BIOLOGICAL

Intravenous (IV) infusions of panitumumab 2.5 mg/kg once a week delivered in 6-week cycles.

Also known as: ABX-EGF

Part 1: Panitumumab + IFL; Part 2: Panitumumab + FOLFIRI

5-Fluorouracil DRUG

Part 1: IV bolus 500 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: IV bolus 400 mg/m\^2 and infusional 2400-3000 mg/m\^2 over 46 hours once every other week until disease progression or unable to tolerate.

Part 1: Panitumumab + IFL; Part 2: Panitumumab + FOLFIRI

Leucovorin DRUG

Part 1: IV bolus 20 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: 400 mg/m\^2 every other week until disease progression or unable to tolerate.

Part 1: Panitumumab + IFL; Part 2: Panitumumab + FOLFIRI

Eligibility Criteria

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

You may qualify if:

• Able to comprehend and sign an Institutional Review Board (IRB)-approved informed consent form
• Pathologic diagnosis of colorectal cancer - Metastatic colorectal adenocarcinoma
• If history of adjuvant chemotherapy for colorectal cancer, must have been free of disease for greater than or equal to 1 year after completion of adjuvant chemotherapy
• Unidimensionally measurable disease
• Paraffin-embedded tumor tissue available for immunohistochemistry studies of epidermal growth factor receptor (EGFr) expression (archived tissue is acceptable)
• Tumor over-expressing EGFr by immunohistochemistry (staining must be the sum of 1+, 2+ and 3+ in greater than or equal to 10% of evaluated tumor cells; staining and evaluation to be conducted at a central laboratory)
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
• Adequate hematologic, renal, and hepatic function

You may not qualify if:

• Female (of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized, or not abstinent) not consenting to use adequate contraceptive precautions during the course of the study and for 6 months after the last ABX-EGF infusion
• Female who is breast-feeding or pregnant
• Any kind of disorder that compromises the ability of the patient to give written informed consent and/or comply with the study procedures
• History of any chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study drug administration or may interfere with compliance or the interpretation of study results
• Untreated brain metastases
• Therapy for colorectal cancer other than surgery and 5-FU-based adjuvant therapy
• Prior treatment for metastatic colorectal cancer
• Prior irinotecan
• Prior or concurrent radiation therapy for colorectal cancer, including prior adjuvant radiation therapy to the pelvis
• Known allergy to irinotecan, 5-fluorouracil, or leucovorin
• Known Gilbert's disease
• Known dihydropyrimidine dehydrogenase (DPD) deficiency
• Prior EGFr-targeting agents
• Use of investigational therapy used with adjuvant intent within 30 days before the first ABX-EGF infusion
• If prior history of cancer other than colorectal carcinoma, basal cell carcinoma, or cervical carcinoma in situ, no treatment or active disease within 5 years

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Berlin J, Posey J, Tchekmedyian S, Hu E, Chan D, Malik I, Yang L, Amado RG, Hecht JR. Panitumumab with irinotecan/leucovorin/5-fluorouracil for first-line treatment of metastatic colorectal cancer. Clin Colorectal Cancer. 2007 Mar;6(6):427-32. doi: 10.3816/CCC.2007.n.011.

  PMID: 17531105 BACKGROUND

Related Links

• AmgenTrials clinical trials website
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Panitumumab; Fluorouracil; 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)

Camptothecin; Alkaloids; Heterocyclic Compounds; 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; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2005
• First Posted: May 26, 2005
• Study Start: July 1, 2002
• Primary Completion: February 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 12, 2013
• Results First Posted: June 3, 2011

Record last verified: 2013-11