Clinical trial · Interventional
A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer
NCT01801904CI-TRIAL-00064996PACERunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Panitumumab | Drug | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Panitumumab
- interventionNames
- Drug: Panitumumab
Primary outcomes (1)
- measure
- number of patients alive and without disease progression
- timeFrame
- 2 months
- description
- progression of disease within 2 months from registration according to RECIST criteria, and death for any cause within 2 months from registration
Secondary outcomes (4)
- measure
- response rate
- timeFrame
- up to 40 weeks
- description
- Response assessed per patients at weeks 8,16,24,32,40 and every 3 months thereafter, using RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPiccirillo 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