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

Metastatic Colorectal Cancer Clinical Trial

— PACER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01801904
• Other study ID #: PACER
• Secondary ID: 2010-024490-39
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Panitumumab
6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute, Naples	Azienda Ospedaliera G. Rummo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	gene expression on tumor tissue	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
Primary	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	2 months
Secondary	response rate	Response assessed per patients at weeks 8,16,24,32,40 and every 3 months thereafter, using RECIST criteria	up to 40 weeks
Secondary	progression free survival		9 months
Secondary	overall survival		one year
Secondary	worst grade toxicity per patient	worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 3) per patient	every 2 weeks for up to 6 months