PACER: A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Panitumumab
|
Drug: Panitumumab
6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity
|
Outcome Measures
Primary Outcome Measures
- number of patients alive and without disease progression [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
- response rate [up to 40 weeks]
Response assessed per patients at weeks 8,16,24,32,40 and every 3 months thereafter, using RECIST criteria
- progression free survival [9 months]
- overall survival [one year]
- worst grade toxicity per patient [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
- gene expression on tumor tissue [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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pathologic diagnosis of metastatic colorectal adenocarcinoma
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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
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Failure from previous treatment with fluoropyrimidine, oxaliplatin and irinotecan. Patients may or may not have been treated with bevacizumab.
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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.
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Age at least 18 years
-
ECOG Performance Status 0-2
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Neutrophils at least 1,500 mm3, platelets at least 100,000 mm3, and hemoglobin at least 9 g/dL
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Bilirubin level less than 1.5 times ULN
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AST (SGOT) and ALT (SGPT) not greater than 2.5 times ULN (or 5 times ULN in presence of liver metastasis)
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Serum creatinine less than 1.5 times ULN
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Effective contraception, if the risk of conception exists
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Life expectancy at least 3 months
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Written informed consent
Exclusion Criteria:
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Symptomatic brain metastasis
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Interstitial pneumonitis or pulmonary fibrosis
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Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
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Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliera G. Rummo | Benevento | BN | Italy | |
| 2 | Ospedale Fatebenefratelli | Benevento | Italy | ||
| 3 | A.O.U. Policlinico Federico II | Napoli | Italy | ||
| 4 | Istituto Nazionale dei Tumori | Napoli | Italy | ||
| 5 | Casa Sollievo Sofferenza | S. Giovanni Rotondo | Italy |
Sponsors and Collaborators
- National Cancer Institute, Naples
- Azienda Ospedaliera G. Rummo
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PACER
- 2010-024490-39