Bevacizumab, Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

NCT00387699 | Completed Phase 2

• 2 other identifiers: CDR0000508653ECOG-E1506
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with cisplatin, etoposide, and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer.

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 1 year

Secondary Outcomes (2)

• Response rate

• Toxicity

Interventions

bevacizumab BIOLOGICAL

cisplatin DRUG

etoposide DRUG

radiation therapy RADIATION

Eligibility Criteria

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

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bevacizumab; Cisplatin; Etoposide; Radiotherapy

Condition Hierarchy (Ancestors)

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Therapeutics

Study Officials

• Afshin Dowlati, MD

  Case Comprehensive Cancer Center

  STUDY CHAIR

• James A. Bonner, MD

  University of Alabama at Birmingham

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: April 1, 2014
• Last Updated: April 28, 2015

Record last verified: 2008-10