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Home > "C" Clinical Trials Conditions > Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer  Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
For Condition: extensive stage small cell lung cancer
Status: Not yet recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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 locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of extensive-stage small cell lung cancer by stopping blood flow to the tumor. Combining chemotherapy with a monoclonal antibody may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and etoposide with bevacizumab in treating patients who have previously untreated extensive-stage small cell lung cancer.
Details: OBJECTIVES: Primary - Determine the 1-year progression-free survival of patients with previously untreated extensive stage small cell lung cancer treated with cisplatin, etoposide, and bevacizumab. - Determine the 1-year 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed small cell lung cancer - Extensive stage disease - Measurable or nonmeasurable 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 < 500 mg/24 hours Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No history of thrombotic disorders - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnMurren, , Yale Cancer Center
Additional Information:
Study ID Numbers: CDR0000353484; ECOG-E3501
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079040
Other Extensive Stage Small Cell Lung Cancer Studies:
1. Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
2. CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer
3. Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
4. Combination Chemotherapy With or Without Oblimersen in Treating Patients With Extensive-Stage Small Cell Lung Cancer
5. Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
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