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

NCT01801904 | Unknown Phase 2

• 2 other identifiers: PACER2010-024490-39
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Colorectal Cancer

Keywords

cetuximab-refractory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• response rate

  up to 40 weeks

• progression free survival

  9 months

• overall survival

  one year

• worst grade toxicity per patient

  every 2 weeks for up to 6 months

Other Outcomes (1)

• gene expression on tumor tissue

  one year

Study Arms (1)

Panitumumab

EXPERIMENTAL

Drug: Panitumumab

Interventions

Panitumumab DRUG

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

Panitumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead
• Azienda Ospedaliera G. Rummo: collaborator

Study Sites (5)

Azienda Ospedaliera G. Rummo

Benevento, BN, Italy

Location

Ospedale Fatebenefratelli

Benevento, Italy

Location

A.O.U. Policlinico Federico II

Napoli, Italy

Location

Istituto Nazionale dei Tumori

Napoli, Italy

Location

Casa Sollievo Sofferenza

S. Giovanni Rotondo, Italy

Location

Related Publications (1)

• Piccirillo MC, Avallone A, Carlomagno C, Maiello E, Rosati G, Alabiso O, Nasti G, De Placido S, Latiano TP, Bilancia D, Ottaiano A, De Stefano A, Romano C, Silvestro L, Nappi A, Cassata A, Giordano P, Iaffaioli RV, Normanno N, Perrone F, Daniele B. Multicenter Single-Arm, Two-Stage Phase 2 Study of Panitumumab in Patients With Cetuximab-Refractory Metastatic Colorectal Cancer: The PACER Trial. Clin Colorectal Cancer. 2020 Dec;19(4):270-276. doi: 10.1016/j.clcc.2020.05.009. Epub 2020 May 29.

  PMID: 32631788 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bruno Daniele, M.D.

  Azienda Sanitaria Rummo, Benevento, Division of Medical Oncology

  PRINCIPAL INVESTIGATOR

• Francesco Perrone, M.D., Ph.D

  National Cancer Institute Naples, Italy; Director Clinical Trials Unit

  PRINCIPAL INVESTIGATOR

• Ciro Gallo, M.D., Ph.D

  Second University of Naples, Italy; Chair of Medical Statistics

  PRINCIPAL INVESTIGATOR

• Antonio Gasbarrini, M.D.

  Università Cattolica del S. Cuore, Policlinico Gemelli, Roma

  PRINCIPAL INVESTIGATOR

• Giacomo Carteni', M.D.

  Ospedale Antonio Cardarelli, Napoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: March 1, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (5)