Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer
Brief Summary: The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. There are no data which a possible benefit of second line therapy. for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary.

Irinotecan shows response rates of 20% in the first line therapy with high rates od disease stabilization. There are few trials investigating irinotecan in the second line setting. Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from the company Pfizer.


Options:
A: Inclusion Criteria:

* Signed informed consent
* histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
* Metastatic disease or locally advanced, unresectable disease
* Disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline)
* Organs are functioning well (liver, kidney, blood)
* Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1

Exclusion Criteria:

* First line chemotherapy for metastatic gastric cancer other than platinum/fluoropyrimidine doublet with or without anthracycline
* Previous systemic therapy with other anti-angiogenic drugs
* Uncontrolled high blood pressure
* Symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month
* Evidence of central nervous system (CNS) metastasis at baseline
B: Inclusion Criteria:

* Patient with histologically proven adenocarcinoma of stomach or the gastro-esophageal junction
* Patient with distant metastases laparoscopically proven operative incurability of an locally advanced gastric cancer or patient with a tumor recurrence after gastrectomy
* Patient with progressive disease under a palliative first-line chemotherapy or progressive disease within 6 months after termination of a first-line chemotherapy, defined as objective progression by imaging techniques according to WHO criteria
* Age 18 and 75 years
* Sufficient liver function, defined as serum-bilirubin \<1,5 mg/dl (1,5 upper normal limit), ALT und AST \< 3x upper normal limit
* Sufficient renal function, defined as serum creatinine \< 1,25 x upper normal limit or creatinine clearance \>60ml/min calculated according to Crockroft-Gault
* Contraction for patient with reproductive potential
* Karnofsky-Index \>60%
* Measurable or evaluable tumor manifestation

Exclusion Criteria:

* Tumor progression later than 6 months after termination of first-line chemotherapy
* KI 50% or less
* Patient who have already received a second line chemotherapy for the metastatic setting (adjuvant chemotherapy and one line of palliative chemotherapy os allowed, biologic prior therapies are allowed)
* Prior or current second malignancy despite of basal carcinoma of the skin and curatively treated carcinoma in situ of the cervix
* Uncontrolled infection
* CNS metastases
* Other severe medical illness
* Prior major surgery less than 2 weeks ago
* Parallel treatment with another experimental therapy
* Parallel treatment with another therapy aiming at tumor reduction
* Chronic diarrhea, subileus
* Chronic inflammatory bowel disease or intestinal obstruction
* Pretreatment with irinotecan
C: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.
* Male or female.
* Age 18 -75.
* Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study).
* Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST)
* ECOG Performance status 0, 1 or 2
* Haematological, Biochemical and Organ Function: Neutrophil count \>2.0 × 10 9/L, platelet count \> 100 ×10 9/L. Serum bilirubin\< 1.5 × upper limit of normal (ULN); or, AST or ALT \< 2.5 × ULN (or \< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\< 2.5 × ULN (or \> 5 × ULN in patients with liver metastases,Creatinine clearance \> 60 mL/min.
* Signed informed consent.

Exclusion Criteria:

* prior adjuvant/neoadjuvant therapy more than two regiments.
* Received any investigational drug treatment within 30 days of start of study treatment.
* Patients with active gastrointestinal bleeding.
* Neurological toxicity ≥ grade 2 NCI-CTCAE.
* Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
* History or clinical evidence of brain metastases.
* Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
* Pregnancy women.
* Subjects with reproductive potential not willing to use an effective method of contraception.
* Patients with known active infection with HIV.
* Known hypersensitivity to any of the study drugs.
D: Inclusion Criteria:

* Histologically or cytologically confirmed incurable NSCLC, stage IIIB with a pleural or pericardial effusion or stage IV
* Performance status 0-2
* Diagnosis of advanced NSCLC within the previous eight weeks
* Ability to read and respond to questions in English
* Permission of attending physician

Exclusion Criteria:

* Prior chemotherapy for metastatic disease
* Existence of other co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol

Answer: B