Status:
TERMINATED
A Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy
Lead Sponsor:
Columbia University
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In the past, patients with advanced lung cancer who were inoperable underwent chemotherapy with one or more chemotherapeutic agents. More recently, novel new agents targeting specific enzymes or pathw...
Detailed Description
The majority of patients with NSCLC present with inoperable locally advanced or metastatic disease for which no curative therapy is available. For these patients, platinum based doublet combination re...
Eligibility Criteria
Inclusion
- Have stage IIIB (malignant pleural or pericardial effusion) or stage IV disease.
- Be chemotherapy naïve.
- Have measurable disease by RECIST, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as \>20 mm with conventional techniques or \>10 mm with spiral CT scan; the longest diameter is to be recorded.
- Are 18 years of age or older.
- Have a life expectancy greater than 3 months.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Are able to provide written informed consent in accordance with all applicable regulations and follow the study procedures. Patients must be capable of understanding the investigational nature, potential risks and benefits of the study.
- The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta and the ability to take folic acid, Vitamin B12 and dexamethasone according to protocol.
Exclusion
- Have had prior chemotherapy (or an epidermal growth factor receptor (EGFR TKI) for treatment of advanced disease
- Intrathoracic lung carcinoma of squamous cell histology
- History of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 1 month prior to study enrollment.
- Current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin).
- Current or recent (within 10 days of enrollment) use of aspirin (\>325 mg/day) or chronic use of other NSAIDs.
- Cardiovascular concerns.
- Have had radiation therapy within 2 weeks prior to enrollment.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1.
- Serious, non-healing wound, ulcer, or bone fracture.
- Have inadequate organ function at the Screening visit.
- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
- Have uncontrolled active systemic infection requiring treatment.
- Have had treatment for a cancer other than NSCLC within 5 years prior to enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
- Have known human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status or known active hepatitis C infection. Patients assessed by the investigator to be at risk for HIV, hepatitis B or C infection should be tested in accordance with local regulations.
- Are a pregnant or breast-feeding female. Confirmation that the patient is not pregnant must be established by a negative serum Beta-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during the Screening Period. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Are unwilling to employ adequate means of contraception (condoms, diaphragm, birth control pills, injections, intrauterine device, or abstinence).
- Are currently receiving or have previously received an investigational agent for any reason within 4 weeks of enrollment.
- Presence of third space fluid which cannot be controlled by drainage.
- Inability to comply with study and/or follow-up procedures.
- Prior history of hypertensive crisis or hypertensive encephalopathy.
- History of stroke or transient ischemic attack within 6 months prior to Day 1.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00998166
Start Date
June 1 2009
End Date
October 1 2011
Last Update
July 30 2024
Active Locations (2)
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1
North Shore University Hospital
Lake Success, New York, United States, 11042
2
Columbia University Medical Center
New York, New York, United States, 10032