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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01801904
Recruitment Status : Active, not recruiting
First Posted : March 1, 2013
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
Azienda Ospedaliera G. Rummo
Information provided by (Responsible Party):
National Cancer Institute, Naples

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Panitumumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer
Study Start Date : December 2012
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. progression free survival [ Time Frame: 9 months ]
  3. overall survival [ Time Frame: one year ]
  4. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801904


Locations
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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, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Azienda Ospedaliera G. Rummo
Investigators
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Principal Investigator: 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01801904    
Other Study ID Numbers: PACER
2010-024490-39 ( EudraCT Number )
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Keywords provided by National Cancer Institute, Naples:
cetuximab-refractory
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents