Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.
Brief Summary: The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.


Options:
A: Inclusion Criteria:

* Histologic or cytologic diagnosis pancreatic cancer
* inoperable stage II or stage III or IV disease(UICC, 1997)
* Age 18 to 75 years
* Karnofsky Performance status \> 50
* Signed informed consent

Exclusion Criteria:

* Previous chemotherapy
* Cerebral metastases
* Previous malignancies in past 5 years excluding adequately treated basal or spinocellular skin cancers and insitu cervical cancer
* Leukocytes \< 4000 or neutrophils \< 2000 or platelets \< 100000 or hemoglobin \< 10 g/dl
* Creatinine value \> upper normal limit
* GOT or GPT \> 2.5 times upper normal limit or bilirubin \> 1.5 times upper normal limit in absence of hepatic metastases
* Congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease
* Other concurrent disease that would, in the investigator's opinion, contraindicate the use of the study drugs
* Inability to provide informed consent
* Inability to comply with follow-up.
B: Inclusion Criteria:

* Pathologically confirmed metastatic adenocarcinoma of the pancreas (AJCC Stage IV). Subjects with islet cell neoplasms are excluded
* Non-measurable or measurable disease based on the RECIST criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Life expectancy of \> 3 months
* Hematologic function, as follows:

  * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  * Platelet count ≥ 100 x 109/L
  * Hemoglobin ≥ 9 g/dL (transfusion independent)
* Renal function, as follows:

  * Creatinine ≤ 2.0 mg/dL
* Hepatic function, as follows:

  * Aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases.
  * Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases
  * Bilirubin ≤ 2 x ULN
* INR \< 1.3 (or ≤ 3 if on warfarin for therapeutic anti-coagulation)

Exclusion Criteria:

* Prior systemic therapy for metastatic pancreatic cancer

  * Subjects who have received adjuvant treatment with gemcitabine and who had relapse metastatically are allowed
  * Subjects with advanced local disease who have received treatment with gemcitabine and in whom progression has been observed with the onset of metastases less than 6 months are excluded
* Chemotherapy and/or radiation within 4 weeks of study enrollment
* Prior monoclonal antibody therapy within 60 days of study enrollment
* Known brain or leptomeningeal disease
* History of other primary malignancy, unless:

  * Curatively resected non-melanomatous skin cancer
  * Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years
* Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System)
* Use of any investigational product within 4 weeks of study enrollment
* Major surgery (that requires general anesthesia) within 4 weeks before study enrollment
* Women who are pregnant (confirmed by positive pregnancy test) or lactating
* Man or woman of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for 4 weeks after the last AGS-1C4D4 and/or gemcitabine infusion administration
* Subject known to be human immunodeficiency, hepatitis B or hepatitis C virus positive
* Active serious infection not controlled with antibiotics
C: Inclusion Criteria:

* Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.
* Adequate renal, hepatic and bone marrow function.
* Performance status 0 or 1.

Exclusion Criteria:

* Prior treatment with any systemic chemotherapy for metastatic disease.
* Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors.
* Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.
* Inability to take oral medication.
D: Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
* measurable disease according to RECIST;
* failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
* ECOG performance status of 0-2.

Exclusion Criteria:

* local or locally advanced-resectable pancreatic cancer;
* any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
* major surgery within 2 weeks prior to randomization.

Answer: C