A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer
NCT ID: NCT01801904
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
52 participants
INTERVENTIONAL
2012-12-31
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Panitumumab
Panitumumab
6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity
Interventions
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Panitumumab
6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera G. Rummo
UNKNOWN
National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Bruno Daniele, M.D.
Role: PRINCIPAL_INVESTIGATOR
Azienda Sanitaria Rummo, Benevento, Division of Medical Oncology
Francesco Perrone, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Ciro Gallo, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Second University of Naples, Italy; Chair of Medical Statistics
Antonio Gasbarrini, M.D.
Role: PRINCIPAL_INVESTIGATOR
Università Cattolica del S. Cuore, Policlinico Gemelli, Roma
Giacomo Carteni', M.D.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Antonio Cardarelli, Napoli
Locations
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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
Countries
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References
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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.
Other Identifiers
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2010-024490-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PACER
Identifier Type: -
Identifier Source: org_study_id
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