Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

A Phase 2 study testing Panitumumab in people with Colorectal Cancer and Metastatic Cancer, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer, Metastatic Cancer
What is being tested?: Panitumumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 185 participants
Where: No sites listed yet
Study dates: Mar 2004to Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

About this study

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

Read the 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.

Conditions: Colorectal Cancer, Metastatic Cancer
Being tested: Panitumumab
Keywords: EGFr, Clinical Trial, Panitumumab, ABX-EGF, Immunex, Metastatic Cancer, Vectibix, Abgenix, Amgen
Medical subject headings: Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PanitumumabBiological
Also called ABX-EGF, Vectibix
Panitumumab 6 mg/kg every once 2 weeks weeks administered by intravenous (IV) infusion.

Study groups in NCT00083616
Study group	Role	What they receive
Panitumumab	Experimental	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. Receives: Biological: Panitumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Objective Tumor Response Through Week 16
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.
Measured: 16 weeks
Duration of Response
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.
Measured: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.

Secondary outcomes (7)

Number of Participants With Objective Tumor Response Throughout Study
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.
Measured: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
Time to Response
Median time from enrollment to objective tumor response for participants who responded.
Measured: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
Progression-free Survival Time
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.
Measured: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
Time to Disease Progression
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.
Measured: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
Time to Treatment Failure
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.
Measured: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
Duration of Stable Disease
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.
Measured: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
Overall Survival
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.
Measured: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Dec 2008

First posted28 May 2004 (estimated)
Study startMar 2004
Primary completionMay 2007
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00083616
Sponsor's protocol ID: 20030167
Status last verified: Dec 2013
First submitted: 26 May 2004
Last updated: 10 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 34213592

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Enrolling by invitationObservational study
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RecruitingPhase 2
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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00083616
Acronym / sponsor ID: 20030167
Conditions: Colorectal Cancer, Metastatic Cancer
Keywords: EGFr, Clinical Trial, Panitumumab, ABX-EGF, Immunex, Metastatic Cancer, Vectibix, Abgenix
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Mar 2004
Primary completion: May 2007 (actual)
Study completion: Dec 2008 (actual)
First posted: 28 May 2004 (estimated)
Results: Posted 29 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Panitumumab	Experimental	Biological: PanitumumabParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PanitumumabAlso: ABX-EGF, VectibixPanitumumab 6 mg/kg every once 2 weeks weeks administered by intravenous (IV) infusion.	Biological	Panitumumab

Primary outcome

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.
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.

7 secondary outcomes

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.
Time to Response
Time frame: 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.
Time to Disease Progression
Time frame: 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.
Duration of Stable Disease
Time frame: 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.

Results and safety

Results posted to the registry on 29 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panitumumab (ABX-EGF)	185	154

Primary outcome: Number of Participants With Objective Tumor Response Through Week 16

Time frame: 16 weeks. Number. Unit: Participants

Measure	Panitumumab n = 142
Value	5

Population analysed: Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)

Primary outcome: Duration of Response

Time frame: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.. Median (95% Confidence Interval). Unit: Weeks

Measure	Panitumumab n = 5
Value	14.0 (12.4 to 101.7)

Population analysed: Subset of the Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed obective tumor response

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panitumumab	62 of 182 (34.1%)	176 of 182 (96.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34213592Liao 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.
FDA-approved Drug LabelingLink provided by the sponsor.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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RecruitingObservational study
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Enrolling by invitationObservational study
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panitumumab in people with Colorectal Cancer and Metastatic Cancer, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Objective Tumor Response Through Week 16 (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00083616, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.