Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments bevacizumab, cetuximab, carboplatin, paclitaxel
Phase phase 2
Targets EGFR, VEGF
Sponsor Southwest Oncology Group
Collaborator National Cancer Institute (NCI)
Start date August 2006
End date December 2011
Trial size 90 participants
Trial identifier NCT00368992, CDR0000495363, SWOG-S0536, U10CA032102

Summary

RATIONALE: Monoclonal antibodies, such as cetuximab and 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 carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with paclitaxel, carboplatin, and bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with paclitaxel, carboplatin, and bevacizumab works in treating patients with advanced non-small cell lung cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Frequency and severity of hemorrhage toxicities
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced primary non-small cell lung cancer (NSCLC) meeting 1 of the following criteria: - Newly diagnosed selected stage IIIB disease - T4 lesion due to malignant pleural effusion - Any N - M0 - Newly diagnosed stage IV disease - Any T - Any N - M1 (i.e., distant metastases present) - Recurrent disease after prior surgery and/or radiotherapy (considered stage IV disease) - Any 1 of the following cellular types: - Adenocarcinoma - Large cell carcinoma - Unspecified - No tumor with > 50% squamous cell components - Measurable or nonmeasurable disease as measured by CT scan, MRI, x-ray, or physical exam - Disease must be outside the previous radiation field, area of surgical resection, or a new lesion must be present - Pleural effusions, ascites, or laboratory parameters are not acceptable as the only evidence of disease - No known brain metastases PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - Platelet count ≥ 100,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Hemoglobin ≥ 9 mg/dL - Creatinine normal - Creatinine clearance ≥ 50 mL/min - Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine collection - SGOT or SGPT ≤ 2 times upper limit of normal (ULN) - Bilirubin ≤ 2 times ULN - Alkaline phosphatase ≤ 2 times ULN - INR ≤ 1.5 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after completion of study treatment - No symptomatic neuropathy (sensory) ≥ grade 2 - No documented evidence of acute hepatitis - No active or uncontrolled infection - No history of any of the following: - Cerebral vascular accident within the past 6 months - Myocardial infarction within the past 6 months - Unstable angina within the past 6 months - Uncontrolled hypertension - New York Heart Association class II-IV congestive heart failure - Serious cardiac arrhythmia requiring medication - Clinically significant peripheral vascular disease - No serious or nonhealing wound, ulcer, or bone fracture - No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days - No hemoptysis ≥ ½ teaspoon within the past 3 months - No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies - No significant traumatic injury within the past 28 days - No evidence of bleeding diathesis or coagulopathy - No other prior malignancy within the past 5 years except for the following: - Adequately treated basal cell or squamous cell skin cancer - In situ cervical cancer - Adequately treated stage I or II cancer for which the patient is currently in complete remission - No documented presence of human anti-mouse antibodies (HAMA) PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from prior therapy - At least 3 weeks since prior radiotherapy - At least 4 weeks since prior surgery (e.g., thoracic or other major surgery) and no anticipated need for surgery during study treatment - At least 28 days since prior open biopsy - At least 7 days since prior core biopsy - No prior systemic chemotherapy or biologic therapy for NSCLC - No prior adjuvant therapy for NSCLC - No prior cetuximab, gefitinib, erlotinib, or other investigational agents that target the epidermal growth factor receptor (EGFR) pathway - No prior vascular endothelial growth factor (VEGF)-related agents - No prior chimerized or murine monoclonal antibody therapy - No concurrent full-dose anticoagulation therapy - Concurrent low-dose (1 mg daily) warfarin allowed

Additional Information

Official title A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed By Cetuximab and Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
Description OBJECTIVES: Primary - Evaluate the frequency and severity of hemorrhage toxicities in patients with advanced non-small cell lung cancer treated with induction therapy comprising cetuximab, paclitaxel, carboplatin, and bevacizumab followed by maintenance therapy comprising cetuximab and bevacizumab. Secondary - Evaluate progression-free and overall survival and response rates (confirmed and unconfirmed, complete and partial) in patients treated with this regimen. - Determine the frequency and severity of nonhemorrhage toxicities in patients treated with this regimen. OUTLINE: This is a multicenter study. - Induction therapy: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. - Maintenance therapy: Patients receive cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 years. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Southwest Oncology Group.