Ph I:Bevacizumab + Chemotherapy in Pts w/Malig Pleural Effusion Due to Adv NSCLC

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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 fully filling with air. As a result, you may be experiencing shortness of breath, cough, or chest discomfort. Your doctors have determined that you would feel better if a surgeon or pulmonary specialist removed this fluid immediately. Your doctors are offering to admit you to the hospital, and drain the fluid using a Pleur-XTM catheter.

Once the Pleur-X catheter is in place, your doctors would like to start your chemotherapy.

Your doctors have decided to treat you with chemotherapy. If the chemotherapy works to kill the cancer cells in your body, the cancer will make less fluid, and your doctors will be able to remove the Pleur-XTM catheter sooner.

It is possible that adding a second drug to the chemotherapy, called bevacizumab may make he fluid dry up even faster. It is not known whether adding bevacizumab to chemotherapy for patients with a Pleur-XTM catheter in place is more helpful, or potentially more harmful, than using chemotherapy alone. For this reason, only patients enrolled in this research protocol can receive both chemotherapy and bevacizumab while they have a Pleur-XTM catheter in place.

The purpose of this research study is to determine whether chemotherapy may be delivered safely with a Pleur-XTM catheter in place.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.