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

NCT00089635 | Completed Phase 2 Results

• 1 other identifier: 20030250
• Study Type: interventional
• Target: 203
• 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; Metastases

Keywords

Colon, Rectal Cancer; ABX-EGF, Panitumumab, EGFr; Immunex, Abgenix, Amgen; Metastatic Colorectal Cancer; Vectibix

Outcome Measures

Primary Outcomes (2)

• Objective Tumor Response Through Week 16

  Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.

  From enrollment through Week 16

• Duration of Response

  Kaplan-Meier estimate of time time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first) among participants who had a response at any time on study. Participants who responded and did not progress while on study or who died for reasons other than disease progression while on study were censored at their last evaluable assessment date.

  From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

Secondary Outcomes (7)

• Objective Tumor Response Throughout the Study

  From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

• Time to Initial Objective Response

  From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

• Progression-free Survival Time

  From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

• Time to Disease Progression

  From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

• Time to Treatment Failure

  From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

Study Arms (1)

Panitumumab

EXPERIMENTAL

Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.

Drug: Panitumumab

Interventions

Panitumumab DRUG

Administered by intravenous 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 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 low to negative levels of 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 anti-EGFr antibody therapy with the exception of the small molecule EGFr tyrosine kinase inhibitors, which are permitted
• 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 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

• AmgenTrials clinical trials website
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms

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: August 9, 2004
• First Posted: August 11, 2004
• Study Start: August 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: August 1, 2008
• Last Updated: November 7, 2022
• Results First Posted: December 5, 2013

Record last verified: 2022-11