Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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
Brief Summary: 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.


Options:
A: Inclusion Criteria: - Subject previously randomized to BSC in protocol 20020408 and subsequently determined to have progressive disease - ECOG performance status of 0, 1 or 2 - Adequate hematologic, renal and hepatic function Exclusion Criteria: - Myocardial infarction in time interval between completing 20020408 and enrollment in study - History or evidence of interstitial pneumonitis or pulmonary fibrosis - Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics during the time interval between completing 20020408 protocol and enrollment in this study - Use of systemic chemotherapy or radiotherapy during the time interval between completing 20020408 protocol and enrollment in this study
B: Inclusion Criteria:

* Untreated metastatic colorectal carcinoma
* Age 18 yrs or over
* Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST criteria)
* ECOG performance status 0 or 1
* Life expectancy more than 3 months
* Adequate haematological, renal and liver function
* Tumor tissue available for determination of KRAS mutational status
* Blood sample and paraffin embedded tumor tissue for translational research

Exclusion Criteria:

* Adjuvant therapy within 6 months
* CNS metastases
* Clinically significant atherosclerotic vascular disease
C: 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
D: Inclusion Criteria:

* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
* Inoperable metastatic disease
* Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue
* Presence of at least 1 bi-dimensionally measurable index lesion

Exclusion Criteria:

* Previous irinotecan-based chemotherapy
* Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment
* Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment
* Brain metastasis

Answer: C