Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI ECOG-E3501 E3501, NCT00079040

Objectives

Primary

1. Determine the 6-month progression-free survival of patients with previously untreated extensive stage small cell lung cancer treated with cisplatin, etoposide, and bevacizumab.
2. Determine the 6-month survival and response rate in patients treated with this regimen.
3. Determine the toxicity of this regimen in these patients.

Secondary

1. Correlate pretreatment plasma levels of vascular endothelial growth factor (VEGF) with response and progression-free and overall survival of patients treated with this regimen.
2. Correlate elevated plasma levels of endothelial cell-specific proteins (VCAM, E-selectin) with response in patients treated with this regimen.
3. 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.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed small cell lung cancer
  • Extensive stage disease



• Measurable disease
  • Previously irradiated lesions must not be the sole site of measurable disease
  • No prior radiotherapy to the site of evaluable disease



• No CNS metastases by CT scan or MRI within the past 4 weeks

Prior/Concurrent Therapy:

Biologic therapy

• No prior immunotherapy for lung cancer
• No prior biologic therapy for lung cancer

Chemotherapy

• No prior chemotherapy for lung cancer

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• No concurrent local radiotherapy for pain control or life-threatening situations

Surgery

• More than 28 days since prior major surgery
• More than 7 days since prior minor surgery or needle biopsies

Other

• No concurrent chronic daily aspirin (> 325 mg/day)
• No concurrent nonsteroidal anti-inflammatory agents known to inhibit platelet function
• No concurrent therapeutic anticoagulation
  • Prophylactic anticoagulation of venous access devices is allowed
• No concurrent treatment with any of the following:
  • Dipyridamole
  • Ticlopidine
  • Clopidogrel
  • Cilostazol

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• No history of hemorrhagic disorders

Hepatic

• Bilirubin ≤ 1.5 mg/dL
• PTT ≤ upper limit of normal
• INR ≤ 1.5

Renal

• Creatinine ≤ 1.5 mg/dL
• Proteinuria < 1+
  • For proteinuria ≥ 1+, urine protein must be ≤ 1 g/24 hours

Cardiovascular

• No symptomatic congestive heart failure
• No cardiac arrhythmia
• No history of thrombotic disorders
• No clinically significant peripheral artery disease
• No arterial thromboembolic event within the past 6 months, including any of the following:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Unstable angina
  • Myocardial infarction
• Hypertension must be well-controlled (≤ 150/85) on a stable regimen of antihypertensive therapy

Pulmonary

• No history of gross hemoptysis (i.e., ≥ 1 teaspoon of bright red blood)

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study treatment
• No other malignancy within the past 5 years except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No serious nonhealing wound, ulcer, or bone fracture

Expected Enrollment

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

Outcomes

Disease progression at 6 months

Objective response rate
Overall survival
Toxicity

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 2 months for up to 3 years from study entry.

Sandler A, Szwaric S, Dowlati A, et al.: A phase II study of cisplatin (P) plus etoposide (E) plus bevacizumab (B) for previously untreated extensive stage small cell lung cancer (SCLC) (E3501): a trial of the Eastern Cooperative Oncology Group. [Abstract] J Clin Oncol 25 (Suppl 18): A-7564, 400s, 2007.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Alan Sandler, MD, Protocol chair		Ph: 615-343-4070; 800-811-8480 Email: alan.sandler@vanderbilt.edu

Registry Information
Official Title		A Phase II Study of Cisplatin Plus Etoposide (PE) Plus Bevacizumab (NSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer
Trial Start Date		2004-06-08
Registered in ClinicalTrials.gov		NCT00079040
Date Submitted to PDQ		2004-01-20
Information Last Verified		2007-09-21
NCI Grant/Contract Number		CA21115

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