Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

NCT00083616 | Completed Phase 2 Results DMC

• 1 other identifier: 20030167
• Study Type: interventional
• Target: 185
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

EGFr; Clinical Trial; Panitumumab; ABX-EGF; Immunex; Metastatic Cancer; Vectibix; Abgenix; Amgen

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Objective Tumor Response Through Week 16

  Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.

  16 weeks

• Duration of Response

  The time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first); participants who respond and have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. Response (complete or partial response) was assessed per modified WHO criteria by the central IRC. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.

  Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.

Secondary Outcomes (7)

• Number of Participants With Objective Tumor Response Throughout Study

  Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.

• Time to Response

  Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.

• Progression-free Survival Time

  Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.

• Time to Disease Progression

  Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.

• Time to Treatment Failure

  Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.

Study Arms (1)

Panitumumab

EXPERIMENTAL

Participants received panitumumab 6 mg/kg once every 2 weeks weeks administered by intravenous (IV) infusion until progressive disease, inability to tolerate the investigational product, or discontinuation of treatment for other reasons.

Biological: Panitumumab

Interventions

Panitumumab BIOLOGICAL

Panitumumab 6 mg/kg every once 2 weeks weeks administered by intravenous (IV) infusion.

Also known as: ABX-EGF, Vectibix

Panitumumab

Eligibility Criteria

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

You may qualify if:

• Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
• Metastatic colorectal carcinoma
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
• Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required
• Bidimensionally measurable disease
• Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
• At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
• Adequate hematologic, renal and hepatic function

You may not qualify if:

• Symptomatic brain metastases requiring treatment
• Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis
• Use of systemic chemotherapy or radiotherapy within 30 days before enrollment
• Prior epidermal growth factor receptor targeting agents
• Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins with longer serum half-life (e.g., AvastinTM) within 6 weeks before enrollment

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Liao MZ, Prenen H, Dutta S, Upreti VV. The impact of hepatic and renal function on panitumumab exposures in patients with metastatic RAS wild-type colorectal cancer. Cancer Chemother Pharmacol. 2021 Oct;88(4):665-672. doi: 10.1007/s00280-021-04319-w. Epub 2021 Jul 2.

  PMID: 34213592 DERIVED

Related Links

• FDA-approved Drug Labeling
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Panitumumab

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2004
• First Posted: May 28, 2004
• Study Start: March 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: December 1, 2008
• Last Updated: January 10, 2014
• Results First Posted: July 29, 2011

Record last verified: 2013-12