Clinical trial NCT00083616: Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
Official title: A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Metastatic Cancer
Keywords: EGFr
Clinical Trial
Panitumumab
ABX-EGF
Immunex
Metastatic Cancer
Vectibix
Abgenix
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-05-28
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Panitumumab was administered once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons (eg, administrative decision). Participants then attended a safety follow-up visit 4 weeks from the last panitumumab infusion. Participants were subsequently contacted every 3 months from the last panitumumab infusion through month 24 to assess disease status and survival.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Objective Tumor Response Through Week 16
timeFrame: 16 weeks
measure: Duration of Response
timeFrame: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
Secondary outcomes:
measure: Number of Participants With Objective Tumor Response Throughout Study
timeFrame: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
measure: Time to Response
timeFrame: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
measure: Progression-free Survival Time
timeFrame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
measure: Time to Disease Progression
timeFrame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
measure: Time to Treatment Failure
timeFrame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
measure: Duration of Stable Disease
timeFrame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
measure: Overall Survival
timeFrame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.