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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00089635
Recruitment Status : Completed
First Posted : August 11, 2004
Results First Posted : December 5, 2013
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE August 9, 2004
First Posted Date  ICMJE August 11, 2004
Results First Submitted Date  ICMJE August 6, 2010
Results First Posted Date  ICMJE December 5, 2013
Last Update Posted Date October 17, 2018
Actual Study Start Date  ICMJE August 1, 2004
Actual Primary Completion Date January 1, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
  • Objective Tumor Response Through Week 16 [ Time Frame: From enrollment 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.
  • 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. ]
    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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
  • 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. ]
    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. ]
    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. ]
    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. ]
    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. ]
    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. ]
    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. ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Metastases
Intervention  ICMJE Drug: Panitumumab
Administered by intravenous infusion
Other Names:
  • ABX-EGF
  • Vectibix®
Study Arms  ICMJE Experimental: Panitumumab
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.
Intervention: Drug: Panitumumab
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2007)
203
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 1, 2008
Actual Primary Completion Date January 1, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00089635
Other Study ID Numbers  ICMJE 20030250
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Amgen
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Amgen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date September 2018

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