Clinical trial NCT00089635: Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer
Official title: A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Whose Tumors Express Low or Negative EGFr Levels of Immunohistochemistry Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Metastases
Keywords: Colon, Rectal Cancer
ABX-EGF, Panitumumab, EGFr
Immunex, Abgenix, Amgen
Metastatic Colorectal Cancer
Vectibix
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-08-11
Enrollment: 203
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.


Eligibility criteria: Inclusion Criteria:

* 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

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 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

Primary outcomes:
measure: Objective Tumor Response Through Week 16
timeFrame: From enrollment through Week 16
measure: Duration of Response
timeFrame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
Secondary outcomes:
measure: Objective Tumor Response Throughout the Study
timeFrame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
measure: Time to Initial Objective Response
timeFrame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
measure: Progression-free Survival Time
timeFrame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
measure: Time to Disease Progression
timeFrame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
measure: Time to Treatment Failure
timeFrame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
measure: Duration of Stable Disease
timeFrame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
measure: Overall Survival
timeFrame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 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.