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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00089635
First received: August 9, 2004
Last updated: October 7, 2013
Last verified: October 2013

August 9, 2004
October 7, 2013
August 2004
May 2007   (final data collection date for primary outcome measure)
  • Objective Tumor Response Through Week 16 [ Time Frame: From enrollment through Week 16 ] [ Designated as safety issue: No ]
    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.
  • Duration of Response [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ] [ Designated as safety issue: No ]
    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.
Not Provided
Complete list of historical versions of study NCT00089635 on ClinicalTrials.gov Archive Site
  • Objective Tumor Response Throughout the Study [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ] [ Designated as safety issue: No ]
    Confirmed objective tumor response was defined as a complete response or partial response from enrollment through to the data cut-ff date. 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.
  • Time to Initial Objective Response [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ] [ Designated as safety issue: No ]
    Time from date of enrollment to first objective response; participants with stable disease at their last evaluable assessment date were censored at this date and participants with progressive disease while on study were censored after the last response was observed for all participants.
  • Progression-free Survival Time [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death (whichever comes first); participants who did not progress while on study and did not die while on study were censored at their last evaluable assessment date.
  • Time to Disease Progression [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); participants who have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable assessment date.
  • Time to Treatment Failure [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of median time from date of enrollment to date decision was made to end the treatment phase for any reason; participants who complete the treatment phase or who remain in the treatment phase at the completion of the study were censored at this time.
  • Duration of Stable Disease [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ] [ Designated as safety issue: No ]

    Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); in those participants who had a best response of stable disease.

    Stable Disease is defined as neither sufficient shrinkage of index lesions to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir sum of the products of the longest diameters since the treatment started.

  • Overall Survival [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of time to death from any cause; participants who had not died while on study or were lost to follow-up were censored at their last contact date.
Not Provided
Not Provided
Not Provided
 
ABX-EGF (Panitumumab) Monotherapy in Subjects With Metastatic Colorectal Cancer
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

The purpose of this study is to determine that ABX-EGF (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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Metastases
Drug: ABX-EGF (panitumumab)
Panitumumab 6 mg/kg every 2 weeks
Experimental: ABX-EGF
Open-label, single arm
Intervention: Drug: ABX-EGF (panitumumab)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
December 2008
May 2007   (final data collection date for primary outcome measure)

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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00089635
20030250
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP