Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT)
Brief Summary: To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the experimental arm.

N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%


Options:
A: 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
B: Inclusion Criteria:

* Patient undergoing major abdominal surgery (open surgery under general anesthesia lasting more than 45 minutes in the peritoneal and/or retroperitoneal space and/or pelvis).
* Patient \<60 years of age had to have one of the following additional risk factors for VTE:

  * History of VTE,
  * Obesity,
  * Chronic Heart failure,
  * Chronic Respiratory Failure,
  * Inflammatory Bowel Disease,
  * Cancer Surgery.

Exclusion Criteria:

* Any major orthopedic or general surgery in the 3 months prior to study start;
* Clinical signs or symptoms of DVT or PE within the last 12 months or known post phlebitic syndrome;
* Any contra-indications to the performance of venography;
* High risk of bleeding;
* Known hypersensitivity to heparin or Enoxaparin sodium;
* End stage renal disease or patient on dialysis.

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

* histological or cytological pancreatic carcinoma, stage IV A, b
* no preceding radio or chemotherapy of the primarius or the reference lesions
* Karnofsky performance status ≥ 60%
* measurable tumor lesion by spiral CT or MRT not older than 14 days
* no deep venous thrombosis within the last 2 years
* patient compliance and geographical proximity of the residence, which make an adequate follow up possible
* sufficient bone marrow reserve: leukocyte ≥ 3.5 × 109 /l, thrombocyte ≥ 100 × 109 /l
* signed informed consent
* minimum age of 18 years
* women/men must provide sufficient pregnancy prevention

Exclusion Criteria:

* preexisting indication for anti-coagulation of other reason
* bleeding in the last 2 weeks or increased bleeding risk (e.g. serious coagulating disturbance, active stomach or intestine ulzera, or had operational interferences in the last 2 weeks)
* body weight \< 45 kg and/or \> 100 kg
* pregnancy or insufficient preventing methods in the study process
* serious illness, which are incompatible with a study participation
* hypersensitivity to study drugs
* patients with serious kidney malfunction (Creatininclearance \< 30 ml/min)
D: Inclusion Criteria:

* Locally advanced or metastatic NSCLC (stage IIIB or IV)
* Patients who are not candidates for radical combined modality treatments or high-dose radiation therapy
* At least one measurable lesion according to RECIST criteria
* Good performance status
* Adequate haematological, renal and liver function
* Written informed consent

Exclusion Criteria:

* Previous chemotherapy for NSCLC
* Brain metastasis
* History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months
* Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease
* Concomitant therapy with an anti-angiogenesis agent
* Contra-indication for LMWH
* Life expectancy of \< 3 months
* Serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol

Answer: C