Cisplatin, Etoposide & Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00079040

Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or deliver tumor-killing substances to them. Giving chemotherapy with a monoclonal antibody may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together with bevacizumab works in treating patients with previously untreated extensive-stage small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Biological: bevacizumab Drug: cisplatin Drug: etoposide	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Cisplatin Plus Etoposide (PE) Plus Bevacizumab (NSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Etoposide phosphate Bevacizumab

U.S. FDA Resources

Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:

Percentage of Participants Alive and Progression-free (PF) at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 1 year ] [ Designated as safety issue: No ]
Best Objective Response [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	65
Study Start Date:	June 2004
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cisplatin, Etoposide & Bevacizumab	Biological: bevacizumab 15 mg/kg IV infusion over 90 minutes day 1 of a 21-day cycle Other Name: Avastin Drug: cisplatin 60 mg/m2 IV over 30-60 minutes day 1 of a 21-day cycle Drug: etoposide 120 mg/m2 IV over 60 minutes days 1, 2, and 3 of a 21-day cycle

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

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

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 6 weeks for up to 3 years from study entry.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Histologically or cytologically confirmed small cell lung cancer, staged as extensive disease
Measurable disease per RECIST criteria
Previously irradiated lesions must not be the sole site of measurable disease
Age 18 and over
ECOG Performance status 0-2
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
No history of hemorrhagic disorders
Bilirubin ≤ 1.5 mg/dL
PTT ≤ upper limit of normal
INR ≤ 1.5
Creatinine ≤ 1.5 mg/dL
Proteinuria < 1+. For proteinuria ≥ 1+, urine protein must be ≤ 1 g/24 hours
Hypertension must be well-controlled (≤ 150/85) on a stable regimen of antihypertensive therapy
Not pregnant or nursing - patient must have negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study treatment

Exclusion Criteria

Prior radiotherapy to the site of evaluable disease
CNS metastases by CT scan or MRI within the past 4 weeks
Symptomatic congestive heart failure
Cardiac arrhythmia
History of thrombotic disorders
Clinically significant peripheral artery disease
Arterial thromboembolic event within the past 6 months, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction
History of gross hemoptysis (i.e., ≥ 1 teaspoon of bright red blood)
Other malignancy within the past 5 years except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Ongoing or active infection
Psychiatric illness or social situation that would preclude study compliance
Serious nonhealing wound, ulcer, or bone fracture
Prior immunotherapy for lung cancer
Prior biologic therapy for lung cancer
Prior chemotherapy for lung cancer
Concurrent local radiotherapy for pain control or life-threatening situations
Prior major surgery within 28 days
Prior minor surgery or needle biopsies within 7 days
Concurrent chronic daily aspirin (> 325 mg/day)
Concurrent nonsteroidal anti-inflammatory agents known to inhibit platelet function
Concurrent therapeutic anticoagulation, but prophylactic anticoagulation of venous access devices is allowed
Concurrent treatment with Dipyridamole, Ticlopidine, Clopidogrel, Cilostazol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079040

Show 60 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Alan B. Sandler, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Sandler A, Szwarc 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.

Responsible Party:	Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00079040 History of Changes
Other Study ID Numbers:	CDR0000353484, ECOG-E3501
Study First Received:	March 8, 2004
Results First Received:	November 19, 2009
Last Updated:	February 3, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:

extensive stage small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Bevacizumab

Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012