Phase I of Bevacizumab Plus Chemotherapy in Patients With Malignant Pleural Effusion Due to Advanced Non-Small Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
Phase I of Bevacizumab Plus Chemotherapy in Patients With Malignant Pleural Effusion Due to Advanced Non-Small Cell Lung Cancer
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 defined in protocol Section 6.0). All patients will undergo placement of a
Pleur-XTM catheter as part of routine practice. Eligible patients may enroll in the
protocol prior to, or within 10 days following placement of their Pleur-XTM catheter. Upon
enrollment, patients will be given a logsheet on which to record the volume of pleural fluid
drained from their catheter. Only patients who, in the opinion of the treating physician,
do not have a hemorrhagic pleural effusion (grossly bloody, or pleural fluid hemoglobin
concentration > 25% of blood hemoglobin concentration) may remain on study. In addition,
only patients who, in the opinion of the treating physician, have satisfactory placement of
their Pleur-XTM catheter may remain on study.
Approximately 15 patients will be enrolled with the goal to treat 10 patients with
chemotherapy plus bevacizumab. The additional enrollments will be necessary in that it is
estimated that approximately 1 in 3 patients will be taken off study due to failure of
Pleur-XTM catheter placement, or discovery of hemorrhagic effusion.
Patients who remain on study will begin chemotherapy. All eligible 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.
Acceptable chemotherapy regimens for this protocol are detailed in Section 5.0 of the
protocol. Only the administration of bevacizumab will be governed by the protocol (Section
11.0). Dose reductions of all other drugs will be made according to routine clinical
practice. Pleural fluid will be drained from the Pleur-XTM at least every other day (qod),
and volume recorded by the patient in a log book. Pleur-XTM catheters may be removed when
pleural symphysis is achieved (defined in Section 12.0), or at the discretion of the
treating physician. The schedule of follow-up visits may vary according to the chemotherapy
regimen, however all patients must be evaluated in the clinic at least every 3 weeks with a
doctor visit to record drainage volume, and status of their Pleur-XTM catheter.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
end of study
Safety Issue:
Yes
Principal Investigator
Christopher G. Azzoli, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
05-089
NCT ID:
NCT00250978
Start Date:
November 2005
Completion Date:
April 2008
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Advanced Non Small Cell Lung Cancer
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Pleural Effusion
- Pleural Effusion, Malignant
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
