Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or deliver tumor-killing substances to them. Giving chemotherapy with a monoclonal antibody may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together with bevacizumab works in treating patients with previously untreated extensive-stage small cell lung cancer.

Further Study Information

OBJECTIVES:

Primary

• Determine the 6-month progression-free survival of patients with previously untreated extensive stage small cell lung cancer treated with cisplatin, etoposide, and bevacizumab.

• Determine the 6-month survival and response rate in patients treated with this regimen.

• Determine the toxicity of this regimen in these patients.

Secondary

• Correlate pretreatment plasma levels of vascular endothelial growth factor (VEGF) with response and progression-free and overall survival of patients treated with this regimen.

• Correlate elevated plasma levels of endothelial cell-specific proteins (VCAM, E-selectin) with response in patients treated with this regimen.

• Correlate pre- and post-treatment plasma levels of basic fibroblast growth factor with response and progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

• Chemotherapy: Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

• Bevacizumab therapy: Beginning concurrently with chemotherapy, patients receive bevacizumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks for up to 3 years from study entry.

PROJECTED ACCRUAL: A total of 27-66 patients will be accrued for this study within 3-8 months.

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed small cell lung cancer, staged as extensive disease

• Measurable disease per RECIST criteria

• Previously irradiated lesions must not be the sole site of measurable disease

• Age 18 and over

• ECOG Performance status 0-2

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• No history of hemorrhagic disorders

• Bilirubin ≤ 1.5 mg/dL

• PTT ≤ upper limit of normal

• INR ≤ 1.5

• Creatinine ≤ 1.5 mg/dL

• Proteinuria < 1+. For proteinuria ≥ 1+, urine protein must be ≤ 1 g/24 hours

• Hypertension must be well-controlled (≤ 150/85) on a stable regimen of antihypertensive therapy

• Not pregnant or nursing - patient must have negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study treatment

Exclusion Criteria

• Prior radiotherapy to the site of evaluable disease

• CNS metastases by CT scan or MRI within the past 4 weeks

• Symptomatic congestive heart failure

• Cardiac arrhythmia

• History of thrombotic disorders

• Clinically significant peripheral artery disease

• Arterial thromboembolic event within the past 6 months, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction

• History of gross hemoptysis (i.e., ≥ 1 teaspoon of bright red blood)

• Other malignancy within the past 5 years except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• Ongoing or active infection

• Psychiatric illness or social situation that would preclude study compliance

• Serious nonhealing wound, ulcer, or bone fracture

• Prior immunotherapy for lung cancer

• Prior biologic therapy for lung cancer

• Prior chemotherapy for lung cancer

• Concurrent local radiotherapy for pain control or life-threatening situations

• Prior major surgery within 28 days

• Prior minor surgery or needle biopsies within 7 days

• Concurrent chronic daily aspirin (> 325 mg/day)

• Concurrent nonsteroidal anti-inflammatory agents known to inhibit platelet function

• Concurrent therapeutic anticoagulation, but prophylactic anticoagulation of venous access devices is allowed

• Concurrent treatment with Dipyridamole, Ticlopidine, Clopidogrel, Cilostazol

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Alan B. Sandler

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00079040
Information obtained from ClinicalTrials.gov on December 15, 2011

Back to Top