A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer (PACER)

March 23, 2023 updated by: National Cancer Institute, Naples
The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study was amended with modification of inclusion criteria (from wild-type tumor KRAS gene to wild-type RAS gene, including KRAS and NRAS exons 2, 3 and 4)

RAS mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. Patients whose tumors will result RAS mutated at the biomarkers central revision, will be replaced. Therefore, the overall sample size at both the stages may be higher than the one initially planned.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Benevento, Italy
        • Ospedale Fatebenefratelli
      • Napoli, Italy
        • A.O.U. Policlinico Federico II
      • Napoli, Italy
        • Istituto Nazionale dei Tumori
      • S. Giovanni Rotondo, Italy
        • Casa Sollievo Sofferenza
    • BN
      • Benevento, BN, Italy
        • Azienda Ospedaliera G. Rummo

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 metastatic colorectal adenocarcinoma
  • a wild-type RAS tumor (mutational status has to be determined by an experienced laboratory using validated test methods for detection of KRAS exons 2, 3, and 4, and NRAS exons 2, 3, and 4
  • Failure from previous treatment with fluoropyrimidine, oxaliplatin and irinotecan. Patients may or may not have been treated with bevacizumab.
  • Documented disease progression following a treatment with cetuximab in patients who showed either an objective response after 8 weeks or stable disease after 16 weeks of cetuximab treatment.
  • Age at least 18 years
  • ECOG Performance Status 0-2
  • Neutrophils at least 1,500 mm3, platelets at least 100,000 mm3, and hemoglobin at least 9 g/dL
  • Bilirubin level less than 1.5 times ULN
  • AST (SGOT) and ALT (SGPT) not greater than 2.5 times ULN (or 5 times ULN in presence of liver metastasis)
  • Serum creatinine less than 1.5 times ULN
  • Effective contraception, if the risk of conception exists
  • Life expectancy at least 3 months
  • Written informed consent

Exclusion Criteria:

  • Symptomatic brain metastasis
  • Interstitial pneumonitis or pulmonary fibrosis
  • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
  • Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks
  • Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study drugs or render the patient at high risk from treatment complications
  • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Panitumumab
Drug: Panitumumab
6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients alive and without disease progression
Time Frame: 2 months
progression of disease within 2 months from registration according to RECIST criteria, and death for any cause within 2 months from registration
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate
Time Frame: up to 40 weeks
Response assessed per patients at weeks 8,16,24,32,40 and every 3 months thereafter, using RECIST criteria
up to 40 weeks
progression free survival
Time Frame: 9 months
9 months
overall survival
Time Frame: one year
one year
worst grade toxicity per patient
Time Frame: every 2 weeks for up to 6 months
worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 3) per patient
every 2 weeks for up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
gene expression on tumor tissue
Time Frame: one year
exploratory analysis of tumor-tissue for biological or genomic determinants of outcome of BRAF and P13K mutation status, EGFR and PTEN expression status
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Collaborators

Azienda Ospedaliera G. Rummo

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.

General Publications

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

December 1, 2012

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACER
  • 2010-024490-39 (EudraCT Number)

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.

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