Please select the eligibility criteria that correspond to the clinical trial below.
Title: FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer
Brief Summary: RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients with lung cancer. It is not yet known whether dalteparin is effective in preventing blood clots in patients with lung cancer.

PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing blood clots in patients with lung cancer.


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:

1. Patients with the diagnosis of advanced stage (unresectable or metastatic) adenocarinoma of the pancreas. Patients with borderline resectable will also be eligible if they are starting chemotherapy and/or chemo/radiation therapy (RT) prior to attempting resection.
2. Patients must be planning to initiate systemic chemotherapy within 2 weeks. Chemotherapy that is being given concurrently with radiation is allowed.
3. Age \>/= 18 years old
4. Adequate renal function defined as a calculated creatinine clearance of \> 50 mL/min (as reported by the MDACC laboratory using MDRD method or using Cockroft and Gault formula).
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
6. Negative urine or serum pregnancy test in women with childbearing potential, within one week prior to initiation of treatment.
7. Patients must sign an Informed Consent.
8. Patient must agree to transfusion of blood products, when indicated.
9. Ability to administer subcutaneous injections of the study drug by the patient and/or care giver.

Exclusion Criteria:

1. Patients with evidence of venous thrombosis on the initial lower extremity screening ultrasound or incidental VTE of other sites (e.g. PE, Abdominal/pelvic vein thrombosis, etc.).
2. Patients already taking prophylactic or full dose anticoagulation (eg. heparin, low-molecular weight heparin, fondaparinux, or coumadin).
3. Patients with currently active bleeding.
4. The presence of a condition with a high risk for bleeding, including but not limited to active peptic ulcer, recent neurosurgery, or cirrhosis with esophageal varices.
5. Patients with known brain metastases.
6. Patients with a known bleeding diathesis.
7. Patients with a platelet count \< 50,000.
8. Patients with known hypersensitivity to dalteparin.
9. Patients who regularly use medications known to increase the risk of bleeding such as \>/= 325 mg of aspirin daily, or daily clopidogrel, or daily non-steroidal antiinflammatory medications (eg., ibuprofen, naproxen).
C: 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.
D: DISEASE CHARACTERISTICS:

* Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell lung cancer) within the past 6 weeks
* No other intrathoracic tumors (e.g., carcinoid tumor, mesothelioma, lymphoma, or lung metastases from another primary site)
* No clinically apparent brain metastases

PATIENT CHARACTERISTICS:

* ECOG performance status 0-3
* Platelet count ≥ 100,000/mm³
* Serum creatinine ≤ 150 µmol/L
* Willing and able to self-administer dalteparin by daily subcutaneous injection or have it administered by a caregiver
* Not pregnant or nursing
* Fertile female patients must use effective contraception (if sexually active)
* No hemorrhagic stroke within the past 3 months
* No known bleeding disorder
* No hemoptysis of CTC ≥ grade 2 (i.e., symptomatic hemoptysis requiring medical intervention)
* No central venous catheter requiring the use of thromboprophylaxis
* No known hypersensitivity to dalteparin, heparin, or other low molecular weight heparins (e.g., history of confirmed or suspected immunologically mediated heparin-induced thrombocytopenia; acute gastroduodenal ulcer; or subacute endocarditis)
* No prior illness likely to interfere with study treatment or comparisons

PRIOR CONCURRENT THERAPY:

* No prior treatment likely to interfere with study treatment or comparisons
* More than 12 months since prior and no concurrent therapeutic anticoagulation
* No concurrent ketorolac (Toradol®)

Answer: D