A Phase 2 Clinical Trial of Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With Metastatic Colorectal Cancer
Aside from limited cases of resectable metastatic disease, mCRC cannot be cured with the
currently available chemotherapy regimens, and there is a continued need to improve the
Panitumumab has demonstrated objective tumour response, increase in progression free
survival and has an acceptable safety profile in clinical studies in patients with
metastatic colorectal cancer when used as a monotherapy or in combination with irinotecan
(Meropol et al, 2003; Berlin et al, 2004; Hecht et al, 2004; Malik et al, 2005).
The addition of panitumumab to chemotherapy is expected to enhance the treatment effect of
This is a Phase II, single-arm, multi-centre study. Eligible subjects will be enrolled and
treated with second-line combination therapy consisting of panitumumab and irinotecan.
Prior to study entry and in order to confirm eligibility, the investigator or designee will
review existing radiological images in addition to any other relevant clinical documents
(reports, notes, etc.) to ensure the subject has failed or relapsed while on or after one
prior chemotherapy regimen.
Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg once Q3W.
Irinotecan chemotherapy (350 mg/m2) will be administered after the administration of
panitumumab. Subjects will be permitted to receive panitumumab and chemotherapy until he or
she develops disease progression (PD) or experiences unacceptable toxicities. Subjects who
discontinue irinotecan, for example due to toxicity, will be permitted to receive
panitumumab monotherapy. After discontinuation of panitumumab, the treatment period will end
and subjects will attend a safety follow-up visit 56 ±3 days later.
Tumour response assessment will be performed by the investigator per the modified Response
Evaluation Criteria in Solid Tumours (m-RECIST). Subjects will be evaluated for tumour
response every 9 weeks ± 1 week until PD or withdrawal from the trial. Responding disease
will be confirmed no less than 28 days after the criteria for response are first met.
Subjects with symptoms suggestive of PD should be evaluated for tumour progression at the
time the symptoms occur.
Subjects will complete an EQ-5D PRO questionnaire every 6 weeks ± 1 week, from baseline
through to the end of the treatment period and at the safety follow-up visit.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
objective response rate
Alfredo Carrato, MD
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Spain: Spanish Agency of Medicines