- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00083616
Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
December 10, 2013 updated by: Amgen
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
185
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Panitumumab
Participants received panitumumab 6 mg/kg once every 2 weeks weeks administered by intravenous (IV) infusion until progressive disease, inability to tolerate the investigational product, or discontinuation of treatment for other reasons.
|
Panitumumab 6 mg/kg every once 2 weeks weeks administered by intravenous (IV) infusion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Objective Tumor Response Through Week 16
Time Frame: 16 weeks
|
Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16.
Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required.
Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions.
Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
|
16 weeks
|
Duration of Response
Time Frame: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
|
The time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first); participants who respond and have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date.
Response (complete or partial response) was assessed per modified WHO criteria by the central IRC.
Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions.
Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
|
Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Objective Tumor Response Throughout Study
Time Frame: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
|
Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, throughout the duration of the study Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required.
Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions.
Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
|
Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
|
Time to Response
Time Frame: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
|
Median time from enrollment to objective tumor response for participants who responded.
|
Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
|
Progression-free Survival Time
Time Frame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
|
Kaplan-Meier estimate of median time from enrollment to death or first observed disease progression (whichever comes first).
Participants who did not progress while on study and did not die while on study were censored at the last evaluable disease assessment date.
|
Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
|
Time to Disease Progression
Time Frame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
|
Kaplan-Meier estimate of the median time from enrollment to first observed disease progression or death if death was due to disease progression (whichever comes first).
Participants who did not progress while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date.
|
Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
|
Time to Treatment Failure
Time Frame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
|
Kaplan-Meier estimate of median time from enrollment to treatment failure, defined as the date the decision was made to end treatment.
Participants remaining in the treatment phase at the time of the analysis were censored on their last visit date.
|
Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
|
Duration of Stable Disease
Time Frame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
|
Kaplan-Meier estimates of the median time from enrollment to the date of first observed disease progression or death due to disease progression among those participants with a best outcome of stable disease.
Stable disease (SD): Neither sufficient shrinkage of Index lesions to qualify for partial response nor sufficient increase to qualify for progressive disease (PD) taking as reference the nadir sum of the products of the longest diameters (SPD) since the treatment started and the disappearance of or persistence of one or more non-index lesions not qualifying for PD.
|
Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
|
Overall Survival
Time Frame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
|
Kaplan-Meier estimate of median time from enrollment to death from any cause.
Deaths were recorded during treatment, safety follow-up and long term follow-up.
|
Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Primary Completion (ACTUAL)
May 1, 2007
Study Completion (ACTUAL)
December 1, 2008
Study Registration Dates
First Submitted
May 26, 2004
First Submitted That Met QC Criteria
May 27, 2004
First Posted (ESTIMATE)
May 28, 2004
Study Record Updates
Last Update Posted (ESTIMATE)
January 10, 2014
Last Update Submitted That Met QC Criteria
December 10, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplasm Metastasis
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Panitumumab
Other Study ID Numbers
- 20030167
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Cancer
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActive, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditionsUnited States
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
University of Roma La SapienzaCompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage IItaly
-
University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States
Clinical Trials on Panitumumab
-
University of Alabama at BirminghamRecruiting
-
Spanish Cooperative Group for the Treatment of...AmgenCompleted
-
Radboud University Medical CenterTerminatedIrresectable Squamous Cell or Adenocarcinoma of the OesophagusNetherlands
-
TakedaCompleted
-
WiSP Wissenschaftlicher Service Pharma GmbHGesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbHTerminatedUrinary Bladder CancerGermany
-
Cliniques universitaires Saint-Luc- Université...Terminated
-
Gruppo Oncologico del Nord-OvestCompletedMetastatic Colo-rectal CancerItaly
-
Hellenic Cooperative Oncology GroupCompleted
-
University of UtahTerminatedKRAS and NRAS Wild-type Colorectal CancerUnited States
-
Matteo's FriendsRecruitingRecurrence Free SurvivalItaly