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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

bevacizumab

cisplatin

etoposide

radiation therapy

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring limited stage small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Outcomes

Primary Outcome Measures

Progression-free survival at 1 year

Secondary Outcome Measures

Response rate

Toxicity

Full Information

NCT ID

NCT00387699

First Posted

October 12, 2006

Last Updated

April 27, 2015

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00387699

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

limited stage small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

79 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

bevacizumab

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

etoposide

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Primary Outcome Measure Information:

Title

Progression-free survival at 1 year

Secondary Outcome Measure Information:

Title

Response rate

Title

Toxicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Afshin Dowlati, MD

Organizational Affiliation

Case Comprehensive Cancer Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

James A. Bonner, MD

Organizational Affiliation

University of Alabama at Birmingham

12. IPD Sharing Statement

Learn more about this trial

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

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