Please select the eligibility criteria that correspond to the clinical trial below.
Title: Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)
Brief Summary: The purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.


Options:
A: Inclusion Criteria:

* 18 years old or older
* Histologically or cytologically confirmed diagnosis of metastatic (Stage IV) adenocarcinoma of the pancreas with measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale
* All prior treatment related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) ≤ Grade 1 (except alopecia) at the time of randomization
* Adequate baseline organ function
* Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels

Exclusion Criteria:

* Prior systemic therapy (i.e., chemotherapy, immunotherapy, hormone therapy, , targeted therapy or any investigational anti-cancer drug) for metastatic pancreatic adenocarcinoma.

(Prior treatment with 5-FU based or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. Prior systemic chemotherapy in the adjuvant setting is allowed ; however, prior therapy with gemcitabine is allowed only if tumor recurrence occurred at least 6 months after completing the last dose of gemcitabine)

* History of another malignancy. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled. Consult GSK Medical Monitor if unsure whether second malignancies meet requirements specified above
* Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator or GSK Medical Monitor
* History of interstitial lung disease or pneumonitis
* History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)
* Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
* History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 6 months
B: 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
C: 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.
D: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the pancreas that is surgically inoperable
* Must have had one prior chemotherapeutic regimen for advanced disease (Prior radiation with a radiation sensitizer for locally advanced disease or adjuvant therapy is not considered a prior regimen for purpose of this study)
* Disease must be measurable by RECIST criteria; measurable disease will be defined as at least one lesion that can be accurately measured in at least one dimension measuring at least 2 cm conventional CT or MRI or 1 cm with spiral CT scans (Appendix A)
* Aged 18 years or older
* ECOG performance status of 0 - 2 (see Appendix B)
* Able to take oral medications without difficulty
* Adequate bone marrow function as evidenced by an ANC \> 1500/mL and platelet count \> 100, 000/mL
* Adequate renal function as evidenced by serum creatinine within institutional limits or creatinine clearance \> 60 ml/minute if above upper institutional limits (ULN)
* Adequate hepatic function as evidenced by ALT, AST, and total bilirubin within ULN. If hepatic metastases are present, ALT and AST may be up to 5 x ULN.
* Provision of written informed consent
* Men and women of childbearing potential must be willing to practice acceptable methods of birth control to prevent pregnancy. This is a precautionary measure for use of Gefitinib and docetaxel.

Exclusion Criteria:

* Known severe hypersensitivity to Gefitinib or docetaxel or any of the excipients of these products (i.e. polysorbate 80)
* Previous treatment with Gefitinib or docetaxel.
* Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or cervical cancer in situ.
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort
* Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
* Treatment with radiation therapy or chemotherapy within 28 days before Day 1 of trial treatment
* Any unresolved chronic toxicity greater then CTC grade 2 from previous anticancer therapy (except alopecia)
* Incomplete healing from previous oncologic or other major surgery.
* Pregnancy or breast feeding (women of childbearing potential).
* Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.

Answer: C