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

NCT00250978 | Completed Phase 1

• 1 other identifier: 05-089
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Advanced Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To assess the safety and feasibility of administering chemotherapy plus bevacizumab to patients with metastatic NSCLC and MPE following insertion of a Pleur-XTM catheter.

  end of study

Interventions

bevacizumab with chemotherapy, Pleur-XTM catheter placement DRUG

After Pleur-XTM catheter placement patients will receive bevacizumab 15mg/kg IV x 1 dose as a single agent.Three weeks later, chemotherapy will be initiated according to routine clinical practice along with continued use of bevacizumab.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Christopher G. Azzoli, M.D.

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 9, 2005
• Study Start: November 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 30, 2008

Record last verified: 2008-04

Locations

US (1)