Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-center, Open-label, Randomized, Phase 2 Clinical Trial Evaluating Safety and Efficacy of FOLFIRI With Either Panitumumab or Bevacizumab as Second-Line Treatment in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Tumors
Brief Summary: This is a multi-center, open-label, randomized, phase 2, two-arm clinical trial to be conducted in the United States. Approximately 210 eligible KRAS wild-type expressing metastatic colorectal cancer subjects who have failed first-line oxaliplatin-based chemotherapy (with at least 4 doses of oxaliplatin-based chemotherapy) with at least 4 doses of bevacizumab (failure is defined as toxicity due to oxaliplatin-based chemotherapy or progression of disease on first-line treatment) will be randomized in a 1:1 ratio to receive either a once-every-two-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg or a Q2W FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care).


Options:
A: Participants who met the following main selection criteria were included in the study.

Inclusion Criteria:

* Histologically or cytologically proven adenocarcinoma of the colon or rectum
* Metastatic disease that is not amenable to potentially curative treatment
* One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible)
* Prior treatment with bevacizumab is permitted.

Exclusion Criteria:

* Prior therapy with irinotecan
* Eastern Cooperative Oncology Group performance status \>2

The above information is not intended to contain all considerations relevant to participation in a clinical trial.
B: Inclusion Criteria

* Diagnosis of metastatic adenocarcinoma of the colon or rectum that cannot, in the opinion of the investigator, be cured by surgical resection at the time of randomization
* Wild-type KRAS expressing mCRC from the primary tumor or metastasis.
* Failure of prior first-line oxaliplatin-based chemotherapy with bevacizumab (at least four therapeutic doses of oxaliplatin-based chemotherapy and bevacizumab) for mCRC.
* At least one uni-dimensionally measurable lesion per modified RECIST criteria.
* Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Man or woman 18 years of age or older
* Hematology, chemistry, coagution, metabolic functions within normal or protocol-defined limits

Exclusion Criteria

* Previous irinotecan, anti-EGFr therapy (eg, cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) or vaccine for the treatment of mCRC
* Radiotherapy ≤ 14 days before randomization
* Evidence of central nervous system (CNS) metastases
* Unresolved toxicities from prior anti-cancer therapy that, in the opinion of the investigator, precludes subject from participation
* History of other invasive primary cancer, except:
* Curatively resected or treated non-melanomatous skin cancer
* Curatively treated cervical carcinoma in situ
* Other primary solid tumor treated curatively and no treatment administered ≤ 2 years before randomization and, in the investigator's opinion, it is unlikely that there will be a recurrence ≤ 2 years post randomization

Medications

* C hronic daily treatment (as determined by the investigator) with aspirin (\> 325 mg/day) or non steroidal anti inflammatory agents known to inhibit platelet function
* Infection requiring a course of systemic anti-infectives that was completed ≤ 14 days before randomization (exception can be made at the judgment of the investigator for oral treatment of an uncomplicated urinary tract infection \[UTI\])
* Subjects concurrently receiving any investigational agent or therapy ≤ 30 days before randomization

General:

* Significant cardiovascular risk as defined by the protocol
* History of peripheral arterial ischemia ≤ 24 weeks before randomization (subjects with brief, reversible, exercise-induced claudication are eligible)
* History of visceral arterial ischemia ≤ 24 weeks before randomization
* Significant bleeding risk:
* Major surgical procedure, open biopsy, or significant traumatic injury ≤ 28 days before randomization
* Anticipation of need for major surgical procedures during the course of the study
* C ore biopsy or other minor procedure, excluding placement of a vascular access device ≤ 7 days before randomization
* A ny significant bleeding that is not related to the primary colon tumor ≤ 24 weeks before randomization
* P re-existing bleeding diathesis or coagulopathy with the exception of well-controlled chronic anticoagulation therapy
* Serious or non-healing wounds, skin ulcers, or unhealed bone fractures
* Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 28 days before randomization
* History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest x-ray (CXR) or computed tomography (CT) scan
* Clinically significant ascites
* Subjects known to be human immunodeficiency virus (HIV) positive or known to have chronic or active hepatitis B or C infection
* Men and women of childbearing potential (women who are post-menopausal \< 52 weeks, not surgically sterilized, or not abstinent) who do not consent to use adequate contraception (according to institutional standard of care) during the course of the study and after the last date of receiving second-line treatment (24 weeks for women, 4 weeks for men)
* Women who test positive for serum or urine pregnancy test ≤ 72 hours before randomization or are breast-feeding
* Subjects allergic to any component that is part of the treatment regimen
C: Inclusion Criteria:

* Adult patients, \>=18 years of age
* Metastatic colorectal cancer and disease progression
* Previously treated with first-line chemotherapy plus Avastin
* Eastern Cooperative Oncology Group (ECOG) performance status \<=2.

Exclusion Criteria:

* Diagnosis of progression of disease more than 3 months after last Avastin administration
* First-line patients with progression-free survival in first-line of \<3 months
* Patients receiving less than 3 consecutive months of Avastin in first-line therapy
* Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix
* Clinically significant cardiovascular disease within 6 months prior to start of study treatment
* Known central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol
D: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, metastatic disease
* Wild-type KRAS tumor status
* Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2
* Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease
* Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (CRC)
* Adequate hematologic, renal, hepatic and metabolic function

Exclusion Criteria:

* Symptomatic brain metastases requiring treatment
* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
* Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before randomization.
* Clinically significant cardiovascular disease
* Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior to randomization

Answer: B