Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicenter, Randomized, Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer
Brief Summary: Main objective:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases progression-free survival.

Secondary objectives:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting with the onset of chemotherapy, increases global survival, improving the response rates to treatment with CT + RT (radiotherapy) and reduces the incidence of venous thromboembolism (VTE).


Options:
A: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the pancreas

  * Metastatic disease
  * Not amenable to treatment
  * No localized or locally advanced disease
* Measurable disease (metastatic or primary tumor) defined as ≥ 2 cm by CT scan or ≥ 1 cm by spiral CT scan or MRI
* No progressive thrombo-embolic disease
* No adenocarcinoma of the biliary tract or ampulla of Vater
* No known CNS metastases

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy \> 12 weeks
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Alkaline phosphatase \< 5 times normal
* Bilirubin \< 1.5 times normal
* Creatinine \< 1.5 times normal
* Creatinine clearance \< 30 mL/min
* Pain controlled or stabilized via analgesic therapy
* Affiliation with social security system
* Not pregnant or nursing
* No controlled or uncontrolled jaundice
* No contraindication to study drugs
* No cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months
* No serious cardiac and/or respiratory disease
* No other cancer in the past 5 years except the following cancers, provided they have been completely resected:

  * Skin cancer
  * Localized melanoma
  * Carcinoma in situ of the cervix
* No history of thrombophilia
* No history of heparin-induced thrombocytopenia
* No uncontrolled or persistent hypercalcemia
* No psychological, familial, social, and/or geographical condition that precludes participation in the study

PRIOR CONCURRENT THERAPY:

* No prior hematologic therapy for metastatic disease
* No prior abdominal radiotherapy
* No concurrent corticosteroids as anti-emetic therapy
* No other concurrent anticoagulation
B: Inclusion Criteria:

* A newly diagnosed cancer site or progression of the malignant disease after complete or partial remission.
* Initiating a new course of chemotherapy with a minimum intent of 3 months therapy
* A VTE risk stratification score of ≥ 2, according to the scoring method
* Age 18 years old or older
* Provide written informed consent

Exclusion Criteria:

* Lesions or conditions at increased risk of clinically significant bleeding (eg. active peptic ulcer disease)
* Objectively confirmed substantial liver insufficiency as defined by clinical manifestations of ascites, cirrhosis, encephalopathy and/or jaundice and/or biochemical abnormalities in liver function tests including hypoalbuminemia (\< 3.5 gr/dL), elevated levels of total bilirubin (\> 25 umol/L), elevated liver transaminases (2 times the upper limit of normal) and/or biochemical diagnosis of biliary tract obstruction (elevated levels of gamma-glutamyl transferase and alkaline phosphatase, 3 times the upper limit of normal). \*
* Diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome\*\*
* Planned stem cell transplant
* Life expectancy less than 6 months
* Acute or chronic renal insufficiency with glomerular filtration rate (GFR) \< 30 ml/min calculated by the Cockroft and Gault formula.
* Pregnancy\*\*\*
* Continuous anticoagulation with vitamin K antagonists, low-molecular-weight heparin (LMWH), or other oral anticoagulants
* Weight \< 40 Kg
* Platelet count \< 50 x 109/L
* Known allergies to ingredients contained in apixaban
* Use of any contraindicated medications with apixaban
C: Inclusion Criteria:

Cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy

Exclusion Criteria:

* Required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic;
* High risk of bleeding;
* Severe renal impairment (estimated creatinine clearance \<30 mL/min);
* ECOG (Eastern Cooperative Oncology Group) performance status 3 \& 4;
* Major surgery within 4 weeks before randomization;
* Known hypersensitivity to unfractionated heparin \[UFH\] or low molecular weight heparin \[LMWH\].

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
D: Inclusion Criteria:

1. Patients 18 years old or older, of either sex, with a diagnosis of limited small cell lung cancer.
2. Patients with an ECOG functional state less than or equal to 2.
3. Informed consent to participate in the study.
4. Patients with a platelet count above 100,000/microlitre with no hemorrhagic symptomatology.

Exclusion Criteria:

1. Curative or palliative surgery as the initial treatment of their neoplastic condition.
2. Patients with an active hemorrhage in the past two months, organic lesions susceptible to bleeding (e.g. active peptic ulcer, hemorrhagic cerebrovascular accident, aneurysms), history of clinically evident hemorrhagic episodes, major surgery in the past month, outstanding clinically hemoptysis or an increased risk of bleeding due to any homeostatic alteration that contraindicates anticoagulant therapy.
3. Known hypersensitivity to LMWH, heparin or substances of porcine origin.
4. Patients with hypersensitivity to the chemotherapeutic agents used in this protocol that makes it impossible to use the antitumoral regime indicated in this protocol (cisplatin or carboplatin and etoposide), i.e. hypersensitivity to cisplatin and carboplatin or hypersensitivity to etoposide.
5. Patients with congenital or acquired bleeding diathesis.
6. Damage to/ or surgical interventions of the central nervous system, eyes and ears within the past 6 months.
7. Acute bacterial endocarditis or slow endocarditis.
8. Patients with a history of heparin-associated thrombocytopenia or with a current platelet count \< 100,000/mm3
9. Patients with severe renal failure (serum creatinine over 2 mg/dl) or hepatic insufficiency (with values of AST and/or ALT \> 5 times the normal value established in the reference range of the local hospital laboratory).
10. Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure above 120 mmHg).
11. Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
12. Patients with suspected inability/or inability to comply with treatment and/or complete the study.
13. Patients who are participating in another clinical trial or have done so in the past 30 days.
14. Patients with a life expectancy less than 3 months.
15. Patients on treatment with anticoagulants or who have been on treatment during three months before the diagnosis of the tumor.

Answer: D