Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00908960
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative therapies do not exist. Eligible malignancies include:
* Adenocarcinoma of the pancreas (locally advanced or metastatic)
* Colorectal (stage IV)
* Non-small cell lung (unresectable stage III or IV)
* Relapsed ovarian or stage IV
* Surgically unresectable or metastatic gastric adenocarcinoma
* First or second line therapy (within 4 weeks of initiating therapy).
* Minimum age 18 years
* Life expectancy of greater than 6 months
* ECOG Performance Status 0, 1, or 2 (Karnofsky 60% or greater).
* Participants must have normal organ and marrow function as outlined in the protocol.
Exclusion Criteria:
* Participants may not be receiving any other study agents.
* Known brain metastases should be excluded from this clinical trial because of their poor prognosis and higher potential for intracranial hemorrhage.
* Prior history of documented venous thromboembolic event or pulmonary embolism within the last 5 years years (excluding central line associated events whereby patients completed anticoagulation \> 3 months previously)
* Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)
* Any history of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 5 years
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to enoxaparin or heparin.
* History of heparin-induced thrombocytopenia
* Presence of coagulopathy (PT or PTT\> 1.5 x upper limit of normal)
* Familial bleeding diathesis
* Known diagnosis of disseminated intravascular coagulation
* Currently receiving anticoagulant therapy
* Current use of aspirin (\>81mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox), or regular use of non-steroidal anti-inflammatory agents more than twice weekly. Maximum dose of ibuprofen is 400mg no more than twice per week.
* Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00908960
Study Brief:
Protocol Section:
NCT00908960