Clinical trial · Interventional
Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone
A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Chemotherapy to the Efficacy of Chemotherapy Alone in Patients With Previously Treated Metastatic Colorectal Cancer
NCT00339183CI-TRIAL-00061007completedPhase 3Results postedClinicalTrials.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 evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| Panitumumab | Drug | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Panitumumab Plus FOLFIRI
- description
- Participants received panitumumab as an intravenous (IV) infusion at a dose of 6 mg/kg plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-fluorouracil (5-FU), leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
- interventionNames
- Drug: Panitumumab
- Drug: FOLFIRI
- type
- ACTIVE_COMPARATOR
- label
- FOLFIRI Alone
- description
- Participants received standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks.
- interventionNames
- Drug: FOLFIRI
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Man or woman at least 18 years old * Diagnosis of metastatic colorectal cancer (mCRC) * One and only one chemotherapy regimen for mCRC consisting of first-line 5-FU -based chemotherapy * Radiologically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria during treatment or within 6 months of last dose of first-line chemotherapy * At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST * Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2 * Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses * Adequate hematologic, renal, and hepatic functions * Negative pregnancy test within 72 hours of enrollment * Other protocol-specified criteria may apply Exclusion Criteria: * History of or known presence of central nervous system (CNS) metastases * History of another primary cancer within 5 years of randomization * Prior irinotecan therapy * Prior anti-epidermal growth factor receptor (EGFr) antibody therapy or treatment with small molecule EGFr inhibitors * Any investigational agent or therapy within 30 days before randomization * Known allergy or hypersensitivity to irinotecan, 5-FU or leucovorin * History of interstitial lung disease or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan * Active inflammatory bowel disease or other bowel disease causing chronic diarrhea * Known positive tests for human immunodefiency virus (HIV), hepatitis C viris (HCV), acute or chronic active hepatitis B virus (HBV) * Major surgery within 28 days of randomization or minor surgical procedure within 14 days of randomization * Pregnant or breast-feeding * Man or woman of child-bearing potential not consenting to use adequate contraceptive methods or abstinence during the course of the study and for 6 months after last study drug administration (women) or 1 month after last study drug administration (men) * Other protocol-specified criteria may apply
References
Publications (9)
- BACKGROUNDPeeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, Tian Y, Sidhu R. Final results from a randomized phase 3 study of FOLFIRI +/- panitumumab for second-line treatment of metastatic colorectal cancer. Ann Oncol. 2014 Jan;25(1):107-16. doi: 10.1093/annonc/mdt523. PMID 24356622
- BACKGROUNDPeeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, Tzekova V, Collins S, Oliner KS, Rong A, Gansert J. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Nov 1;28(31):4706-13. doi: 10.1200/JCO.2009.27.6055. Epub 2010 Oct 4. PMID 20921462
- BACKGROUNDAuthor and team decided to wait for CALGB RAS data presented Sept 29 at ESMO.
- BACKGROUNDPeeters M, Price T, Taieb J, Geissler M, Rivera F, Canon JL, Pentheroudakis G, Koukakis R, Burdon P, Siena S. Relationships between tumour response and primary tumour location, and predictors of long-term survival, in patients with RAS wild-type metastatic colorectal cancer receiving first-line panitumumab therapy: retrospective analyses of the PRIME and PEAK clinical trials. Br J Cancer. 2018 Aug;119(3):303-312. doi: 10.1038/s41416-018-0165-z. Epub 2018 Jul 17. PMID 30013091
- DERIVEDShi Y, Wan X, Tan C, Li J, Peng L. Model-Based Cost-Effectiveness Analysis of Panitumumab Plus FOLFIRI for the Second-Line Treatment of Patients with Wild-Type Ras Metastatic Colorectal Cancer. Adv Ther. 2020 Feb;37(2):847-859. doi: 10.1007/s12325-019-01214-y. Epub 2020 Jan 4. PMID 31902066
- DERIVEDBoeckx N, Koukakis R, Op de Beeck K, Rolfo C, Van Camp G, Siena S, Tabernero J, Douillard JY, Andre T, Peeters M. Effect of Primary Tumor Location on Second- or Later-line Treatment Outcomes in Patients With RAS Wild-type Metastatic Colorectal Cancer and All Treatment Lines in Patients With RAS Mutations in Four Randomized Panitumumab Studies. Clin Colorectal Cancer. 2018 Sep;17(3):170-178.e3. doi: 10.1016/j.clcc.2018.03.005. Epub 2018 Mar 8.