Status:
COMPLETED
Ph I:Bevacizumab + Chemotherapy in Pts w/Malig Pleural Effusion Due to Adv NSCLC
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Your lung cancer has caused fluid to build up in the space around your lung. This fluid is called a malignant pleural effusion. This fluid takes up space in your chest, and prevents your lung from ful...
Detailed Description
The study will be conducted in patients with advanced NSCLC (stage IIIB-IV) who have MPE requiring therapeutic drainage, and are also eligible for treatment with chemotherapy plus bevacizumab (as defi...
Eligibility Criteria
Inclusion
- Adult patients with pathologically confirmed stage IIIB-IV non-small cell lung cancer who are eligible for systemic chemotherapy, and also have a malignant pleural effusion which requires therapeutic drainage.
- Karnofsky performance status \>=70%
- Adequate coagulation studies, blood counts, renal and hepatic function:
- aPTT \< 33.8 seconds, PT/INR \< 1.12, WBC \>= 3,000/ul, hemoglobin \>= 9.0 g/dl, platelet count \>=100,000/ul, total bilirubin \<= 1.3 mg/dl, AST/ALT \<= 2.0 X UNL, Alk Phos \<= 2.5 X UNL, creatinine \<= 1.5 mg/dl
- Ability to maintain a Pleur-XTM drainage catheter
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Exclusion
- Prior bevacizumab
- Squamous cell histology
- Hemoptysis within the past 3 months that brings up more than 1/2 teaspoon of red blood
- Patients already known to have hemorrhagic pleural effusion, defined as a grossly bloody pleural effusion in the opinion of the treating physician,or pleural fluid hemoglobin concentration \>= 25% of blood hemoglobin concentration .
- Known brain metastases
- Clinically significant cardiovascular disease, uncontrolled hypertension, or peripheralvascular disease
- History of cerebrovascular accident or transient ischemic attack within the past six months
- Pregnancy
- Urine protein: creatinine (UPC) ratio \>= 1.0 at screening
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0
- History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Patients must not be receiving daily treatment with aspirin (\>= 325 mg/day) or daily use of non-steroidal anti-inflammatory agents known to inhibit platelet function including ibuprofen, dipyridamole, ticlopidine, clopidogrel and/or cilostazol.
- Patients must not be on therapeutic anticoagulation with warfarin, heparin or low molecular weight heparin.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00250978
Start Date
November 1 2005
End Date
April 1 2008
Last Update
April 30 2008
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021