Back to results

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

Primary Purpose

Metastatic Colorectal Cancer

Status

Active

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Panitumumab

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring cetuximab-refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Azienda Ospedaliera G. Rummo
Ospedale Fatebenefratelli
A.O.U. Policlinico Federico II
Istituto Nazionale dei Tumori
Casa Sollievo Sofferenza

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Panitumumab

Arm Description

Outcomes

Primary Outcome Measures

number of patients alive and without disease progression

progression of disease within 2 months from registration according to RECIST criteria, and death for any cause within 2 months from registration

Secondary Outcome Measures

response rate

Response assessed per patients at weeks 8,16,24,32,40 and every 3 months thereafter, using RECIST criteria

progression free survival

overall survival

worst grade toxicity per patient

worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 3) per patient

Full Information

NCT ID

NCT01801904

First Posted

January 15, 2013

Last Updated

March 23, 2023

Sponsor

National Cancer Institute, Naples

Collaborators

Azienda Ospedaliera G. Rummo

1. Study Identification

Unique Protocol Identification Number

NCT01801904

Brief Title

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

Acronym

PACER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute, Naples

Collaborators

Azienda Ospedaliera G. Rummo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

Keywords

cetuximab-refractory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Panitumumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Panitumumab

Intervention Description

6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity

Primary Outcome Measure Information:

Title

number of patients alive and without disease progression

Description

progression of disease within 2 months from registration according to RECIST criteria, and death for any cause within 2 months from registration

Time Frame

2 months

Secondary Outcome Measure Information:

Title

response rate

Description

Response assessed per patients at weeks 8,16,24,32,40 and every 3 months thereafter, using RECIST criteria

Time Frame

up to 40 weeks

Title

progression free survival

Time Frame

9 months

Title

overall survival

Time Frame

one year

Title

worst grade toxicity per patient

Description

worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 3) per patient

Time Frame

every 2 weeks for up to 6 months

Other Pre-specified Outcome Measures:

Title

gene expression on tumor tissue

Description

exploratory analysis of tumor-tissue for biological or genomic determinants of outcome of BRAF and P13K mutation status, EGFR and PTEN expression status

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: