An Open-label, Phase II Clinical Trial of Panitumumab in Combination With FOLFIRI Chemotherapy as Second Line Treatment in Subjects With Metastatic Colorectal Cancer Expressing Wild-type KRAS and Who Had Progressed ≥ 6 Months After the Last Dose of the First Line Chemotherapy
This is a Phase II, single-arm, multi-centre study. Patients with metastatic colorectal
cancer expressing wild type KRAS will be screened for this trial. KRAS mutation status will
be assessed before inclusion and only WILD-TYPE-KRAS subjects will be included. Eligible
subjects will be enrolled and treated with combination therapy consisting of Panitumumab and
FOLFIRI as second line treatment.
Eligible patients must not have progressed on or within 6 months after receiving first line
chemotherapy based on fluoropyrimidines and oxaliplatin (prior adjuvant chemotherapy based
on fluoropyrimidine is permitted). Only one previous chemotherapy regimen is permitted.
Progression after 6 months receiving first line chemotherapy regimen, should be
imaging-based.
Tumor response assessment will be performed by the investigator per the modified Response
Evaluation Criteria in Solid Tumors (m-RECIST). Subjects will be evaluated for tumor
response every 6 weeks ± 1 week the first 24 weeks and every 8 weeks thereafter (per the
modified-RECIST criteria) until progression disease (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 progression disease(PD) should be
evaluated for tumor progression at the time the symptoms occur.
All subjects who permanently discontinue the treatment for any reason, will undergo a safety
follow-up assessment 30 days ± 7 days after the last treatment dose Subjects will be
followed for disease status and subsequent cancer therapy. All subjects who discontinue all
the treatment before disease progression (eg, due to unacceptable toxicities) are followed
for progression free survival (PFS) (eg, radiographic tumor assessments) every 12 weeks ± 14
days until disease progression or the end of study (unless the reason for study
discontinuation is fully withdrawn consent). After disease progression, all subjects are
followed every 12 weeks ± 14 days from the safety follow-up visit until the end of study
(approximately 52 weeks after the last subject is enrolled).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
3 years
No
Carles Pericay, MD PhD
Study Chair
Corporació Sanitaria Parc Taulí, Sabadell (Spain)
Spain: Spanish Agency of Medicines
ACROSS-08-01
NCT01144195
September 2009
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