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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 1 year

Safety Issue:

No

Principal Investigator

Afshin Dowlati, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000508653

NCT ID:

NCT00387699

Start Date:

October 2006

Completion Date:

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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