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: INCLUSION CRITERIA:

* both sexes;aged\>18 years;
* suffering from different types of malignancies(lung, breast,gastric,colon- rectum,pancreatic,ovarian,head and neck cancer)undergoing systemic chemotherapy,
* having signed Informed Consent prior to initiation of any study procedure.

EXCLUSION CRITERIA:

* adjuvant and neo-adjuvant chemotherapy;
* objectively confirmed venous or arterial thromboembolism in the last three months;
* antithrombotic treatment for other indications;
* life expectancy of less than 3 months;
* Performance Status\>2(ECOG);
* active bleeding or bleedings in the last four weeks requiring hospitalization,transfusion or surgical intervention;
* bleeding diathesis(prothrombin time\<70% or activated partial thromboplastin time ratio\>1.3),or platelet count\<50x10\^9/L;
* cerebrovascular hemorrhage in the last six months;
* known active gastric or duodenal ulcer;
* known cerebral metastasis;
* cerebral aneurysm;
* III-IV grade diabetic retinopathy;
* severe and uncontrolled hypertension(systolic blood pressure\>180 mmHg or diastolic blood pressure\>110 mmHg);
* chronic atrial fibrillation;
* acute endocarditis;
* acute pancreatitis;
* known hypersensitivity to unfractionated heparin or LMWH;
* previous occurrence of heparin-induced thrombocytopenia;
* renal impairment (dependent on dialysis or creatinine higher than 2.5mg%);
* liver insufficiency (alanine aminotransferase,aspartate aminotransferase,alkaline phosphatase levels\>3 times the upper limit of the normal ranges and/or total bilirubin \>3.0 mg/ml);
* pregnancy or childbearing potential without adequate contraception;
* treatment with other investigational drugs or patient inclusion in other clinical trials;
* patients who are unable to fulfill the study requirements in terms of visits/compliance to treatment.
B: 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.
C: Inclusion Criteria:

1. Histologically or cytologically verified SCLC, all stages
2. WHO performance status 0, 1, 2 or 3
3. Age 18 years or older
4. Intention and feasibility to treat with chemotherapy consisting of platinum + topoisomerase inhibitor.
5. Platelets \>100 x109 /L
6. Signed informed consent
7. PK (prothrombin complex) INR and APTT within normal ranges.

Exclusion Criteria:

1. Prior systemic chemotherapy for lung cancer.
2. Concomitant anticoagulation treatment, except for ASA or clopidogrel
3. Active overt bleeding of clinical importance or at high risk (e.g. earlier observed haemorrhage in a brain metastasis, severe coagulopathy as haemophilia, severe liver dysfunction with impaired coagulation, acute peptic ulcer, and within the last 3 months suffered from intracranial haemorrhage, or surgery in the central nervous system).
4. Any other known contraindication for enoxaparine ( e.g. Hypersensitivity against enoxaparine and its derivatives).
5. Pregnancy or breast-feeding
6. Fertile women not using effective contraceptives or men who do not agree to use effective contraception during the treatment period.
7. Treatment with any other investigational agent, or participation in any other clinical trial.
D: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the pancreas

  * Patients with clinical 'high probability' of pancreatic cancer and biopsy suggestive but not diagnostic of pancreatic cancer may be eligible based on review by the principal investigator
* Measurable or evaluable disease
* No clinical evidence of active venous thromboembolism

PATIENT CHARACTERISTICS:

* Karnofsky performance status (PS) 60-100% OR WHO PS 0-2
* Life expectancy \> 12 weeks
* Absolute neutrophil count \> 2,000/mm³
* WBC \> 3,000/mm³
* Platelet count \> 100,000/mm³
* Creatinine clearance \> 50 mL/min
* INR ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN (stent allowed)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No cerebrovascular accident within the past 6 months
* No obvious contraindication to anticoagulation, including the following:

  * Bleeding diathesis
  * Active peptic ulcer
  * Ulcerating cancer into duodenum
* No history of other advanced malignancy
* No gross hematuria
* No melaena or gross evidence of gastrointestinal bleeding (other than piles)
* No requirement for a central line
* No other significant medial or psychiatric illness that, in the opinion of the investigator, would preclude study participation

PRIOR CONCURRENT THERAPY:

* No prior gemcitabine hydrochloride-containing treatment
* No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), or experimental medications
* No other concurrent specific anticancer therapy as a result of disease progression
* No concurrent caval filter device
* No other concurrent anticoagulants for venous thromboembolism or other reasons (e.g., atrial fibrillation)
* No concurrent acetylsalicylic acid (\> 75 mg) as an antiplatelet drug for a preexisting cardiovascular condition
* No concurrent clopidogrel bisulfate

Answer: B