Cisplatin, Etoposide, and 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:	National Cancer Institute (NCI)
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:	Treatment, Open Label
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 National Cancer Institute (NCI):

Primary Outcome Measures:

Disease progression at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response rate [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	66
Study Start Date:	June 2004
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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 2 months 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

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
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

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

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, 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.

Study ID Numbers:	CDR0000353484, ECOG-E3501
Study First Received:	March 8, 2004
Last Updated:	May 29, 2009
ClinicalTrials.gov Identifier:	NCT00079040 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

extensive stage small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Bevacizumab
Etoposide phosphate
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

Etoposide
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 30, 2009