Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Role of Epidermal Growth Factor Receptor (EGFR) Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib
Brief Summary: The purpose of this study is to investigate the influence of epidermal growth factor receptor mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic cancer.


Options:
A: Inclusion Criteria:

* metastatic chemotherapy-naïve pancreatic cancer patients
* histologically confirmed
* adequate samples for analysis
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
* absolute neutrophil count (ANC) \>= 1,500/mm3
* platelet count \>= 100,000/mm3
* serum creatinine \<= 1.5 mg/dL
* aspartate aminotransferase (AST)
* alanine aminotransferase (ALT) \< 5 times the upper limit of normal

Exclusion Criteria:

* absence of any other malignancy or serious medical or psychological illness that would preclude informed consent
B: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the pancreas

  * No other pancreatic tumor type, including either of the following:

    * Neuroendocrine tumor
    * Acinar cell tumor
  * Metastatic disease
* Measurable disease in an area not previously irradiated
* No cerebral metastases or meningeal involvement of the tumor

PATIENT CHARACTERISTICS:

Age

* 18 to 75

Performance status

* WHO 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed)

Renal

* Creatinine \< 120 mmol/L

Cardiovascular

* No prior myocardial infarction
* No prior angina
* No uncompensated cardiac or coronary insufficiency
* No symptomatic arrhythmia

Gastrointestinal

* No prior inflammatory bowel disease
* No prior chronic diarrhea
* No unresolved symptomatic occlusion or subocclusion of the bowel

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No ongoing active infection
* No other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No contraindication to study treatment
* No other serious medical disorder that would preclude study treatment
* No psychiatric disorder or social or geographic situation that would preclude study participation
* Not detained or under the guardianship of another person

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy

Surgery

* Not specified

Other

* No concurrent participation in another clinical trial using therapeutic experimental agents
C: 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
D: Inclusion Criteria:

* Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamous carcinoma.
* Advanced unresectable pancreatic (including pancreatic cancer with local progression and recurrent pancreatic cancer).Presence/absence of measurable lesions is not considered. Patients with measurable lesions must undergo diagnostic imaging tests within 28 days before registration.
* Patients with no previous treatment (radiotherapy,chemotherapy etc) for pancreatic cancer, except resection. Intra-operative radiotherapy during resection of pancreatic cancer will be permitted, although registration must occur at least 4 weeks after the radiotherapy. Patients that have undergone preoperative/postoperative adjuvant chemotherapy may be enrolled if relapse is diagnosed beyond week 24 after the final administration (on day 169 when the day following the final day is set as day 1).
* Age: 20 years to 79 years.
* ECOG Performance Status (PS) of 0 or 1.
* Sufficient function of major organs as defined below. (The following criteria are satisfied in laboratory tests conducted within 14 days before registration. Laboratory tests conducted 2 weeks before registration (on the same weekday) will be included.) White blood cell count≥ 3500/mm3 Neutrophil count≥ 2000/mm3 Hemoglobin≥9.0 g/dL Platelet count≥100000/mm3 Total bilirubin≤ 2.0 mg/dL\* \*≤ 3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice. AST and ALT≤ 150 U/L Serum creatinine≤1.2 mg/dL Creatinine clearance≥50mL/min.\*\* \*\*Measured values will be used if available. Otherwise, values calculated by the Cockcroft-Gault method will be used.Formula for estimation:body weight (kg) x \[140 - age (years) / 72 x serum creatinine (mg/dL)\] \*Estimated value will be multiplied by 0.85 for females.
* Able to take capsules orally.
* No clinically abnormal ECG findings within 28 days (4 weeks)before registration.
* Voluntarily signed the written consent form.

Exclusion Criteria:

* Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28 days before enrollment).
* Watery diarrhoea.
* Active infections (e.g. patients with pyrexia of 38°C or greater), excluding viral hepatitis.
* Serious complications (e.g. heart failure, renal failure,hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
* Moderate or severe (requiring drainage) ascites or pleural effusion requiring treatment.
* Metastasis in the CNS.
* Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 3 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration.
* Patients under treatment with flucytosine, phenytoin or warfarin potassium.
* Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
* Severe mental disorder.
* Judged ineligible by physicians for participation in the study from a safety viewpoint.

Answer: A