Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma
Brief Summary: This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.


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: DISEASE CHARACTERISTICS:

* Histologically\* or cytologically confirmed pancreatic adenocarcinoma meeting 1 of the following criteria:

  * Locally advanced unresectable disease
  * Distant metastatic disease NOTE: If diagnosis is based on a metastatic site the histology must be compatible with pancreatic cancer
* Measurable or nonmeasurable disease by x-ray, scan, or physical examination
* Tumor tissue must be submitted for evaluation of epidermal growth factor receptor expression before study entry
* None of the following tumor types are allowed:

  * Endocrine tumors
  * Lymphoma of the pancreas
  * Ampullary cancer
* No known brain metastases

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Zubrod 0-2

Life expectancy

* At least 3 months

Hematopoietic

* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 2.0 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2.5 times ULN

Renal

* Creatinine no greater than 2.0 mg/dL

Cardiovascular

* No significant history of cardiac disease
* No uncontrolled hypertension
* No unstable angina
* No uncontrolled arrhythmia
* No congestive heart failure

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior immunotherapy for advanced pancreatic cancer
* No prior cetuximab or other therapy that targets the epidermal growth factor pathway
* No prior chimerized or murine monoclonal antibody therapy
* No other concurrent anticancer immunotherapy

Chemotherapy

* At least 6 months since prior adjuvant chemotherapy
* No prior chemotherapy or chemoradiotherapy for advanced pancreatic cancer
* No prior gemcitabine
* No other concurrent anticancer chemotherapy

Endocrine therapy

* No prior hormonal therapy for advanced pancreatic cancer
* No concurrent anticancer hormonal therapy

Radiotherapy

* See Chemotherapy
* At least 28 days since prior radiotherapy and recovered
* Prior palliative radiotherapy to metastatic sites allowed
* No concurrent anticancer radiotherapy, including whole brain radiotherapy for progressive disease (i.e., CNS metastasis)

Surgery

* At least 14 days since prior pancreatic cancer surgery and recovered

Other

* No other concurrent anticancer therapy
C: Main Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
2. Chemo naïve patients with advanced/metastatic disease
3. Documented decision justifying non eligibility for surgical resection. The documentation of the non eligibility for surgical resection will be reviewed by an independent committee.
4. Men and women, age \>18 years
5. Men and women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test), must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
6. Patient should be able and willing to comply with study visits and procedures as per protocol.
7. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.

Main Exclusion Criteria:

1. Patient treated for a cancer other than pancreatic cancer within 5 years before enrollment, with the exception of basal cell carcinoma or in situ cervical cancer
2. Any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment
3. Any anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy) within 6 months prior to baseline
4. Treatment with any investigational agent within 4 weeks prior to baseline
D: Inclusion Criteria:

* Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening.
* The presence of measurable metastatic pancreatic cancer documented by contrast enhanced CT (or MRI) scan in addition to 1 of the following:

  1. Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
  2. Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:

     1. The presence of a mass in the pancreas OR
     2. A history of resected pancreatic carcinoma
* Measurable disease per RECIST (ver. 1.1)
* ECOG Performance Status of 0 or 1.
* Adequate hepatic, hematologic and renal functions.

Exclusion Criteria:

* A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas.
* A diagnosis of pancreatic islet neoplasms.
* Subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization
* Presence of biliary obstruction requiring external drainage
* Brain metastases.
* Unstable cardiovascular function within the last 6 months of screening
* Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
* Known HIV infection.
* Uncontrolled hypertension at Screening
* History or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment
* Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed.
* Uncontrolled systemic fungal, bacterial or viral infection
* Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study

Answer: D