Completed

Phase II Trial of Bevacizumab in Combination With Cisplatin/Etoposide and Twice Daily Radiation for Patients With Limited-Stage Small Cell Lung Cancer

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What is being tested

Data Collection

Who is being recruted

Bronchial Neoplasms
+7

+ Carcinoma, Bronchogenic
+ Lung Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2006
See protocol details

Summary

Principal SponsorEastern Cooperative Oncology Group
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2006Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the 1-year progression-free survival of patients with limited-stage small cell lung cancer treated with bevacizumab, cisplatin, etoposide, and radiotherapy. Secondary * Determine the toxicity of this regimen in these patients. * Determine the response rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive cisplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. During course 1, patients also undergo thoracic radiotherapy twice daily on days 1-5, 8-12, and 15-19. Patients achieving a complete or partial response or stable disease after the first 4 courses of chemotherapy continue to receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after blood counts recover from the first 4 courses of chemotherapy, patients achieving a complete or partial response also undergo prophylactic cranial irradiation (PCI) in 10 fractions over 3 weeks.\* NOTE: \*Bevacizumab should not be given for 3 weeks prior to or during PCI, but resumed 1 week after completion of PCI. After completion of study treatment, patients are followed periodically for 10 years. PROJECTED ACCRUAL: A total of 79 patients will be accrued for this study.

Official TitlePhase II Trial of Bevacizumab in Combination With Cisplatin/Etoposide and Twice Daily Radiation for Patients With Limited-Stage Small Cell Lung Cancer 
NCT00387699
Principal SponsorEastern Cooperative Oncology Group
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
79 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Small Cell Lung Carcinoma
Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer (SCLC) * Limited-stage disease, defined as SCLC confined to ≥ 1 of the following: * One hemithorax * Ipsilateral supraclavicular fossa * Measurable disease * No malignant pleural effusion, contralateral hilar disease, or contralateral supraclavicular disease * Minimal pleural effusion visible on CT scan of the chest, but not evident on chest x-ray, allowed * No completely surgically resected disease * No CNS disease, including primary brain tumor or brain metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 mg/dL * Creatinine ≤ 1.5 mg/dL * Urine protein:creatinine ratio ≤ 0.5 OR 24-hour urine protein \< 1,000 mg * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment * INR ≤ 1.5 (unless on full-dose anticoagulants) * No active serious infection * No serious or nonhealing wound * No ulcer or bone fracture * No evidence of bleeding diatheses or coagulopathy * No hemoptysis * No known hypersensitivity to Chinese hamster ovary cell products and/or other recombinant human antibodies * No clinically significant cardiovascular disease, including any of the following: * Uncontrolled hypertension * New York Heart Association class II-IV congestive heart failure * Serious cardiac arrhythmia requiring medication * Unstable angina pectoris * Symptomatic peripheral vascular disease * Cerebrovascular accident within the past 6 months * Symptomatic heart disease within the past 6 months * Myocardial infarction within the past 6 months * Unstable angina within the past 6 months * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 4 weeks * No significant traumatic injury within the past 4 weeks PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior major surgery or open biopsy * At least 1 week since prior core biopsy * No prior chemotherapy or radiotherapy for small cell lung cancer * No concurrent major surgery * No concurrent palliative local radiotherapy * No concurrent intensity-modulated radiotherapy * Concurrent full-dose anticoagulants (e.g., warfarin) allowed provided all of the following criteria are met: * INR ≤ 3 * In-range INR (2-3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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