Carboplatin, Paclitaxel, and Bevacizumab With or Without Erlotinib Hydrochloride in Treating Non-Smokers With Advanced Non-Small Cell Lung Cancer

Stopped early · Phase 2

Conditions studied: Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

In brief

This randomized phase II trial studies how well carboplatin, paclitaxel, and bevacizumab work with or without erlotinib hydrochloride in treating non-smokers with advanced non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 carry tumor-killing substances to them. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective with or without erlotinib hydrochloride in treating patients with non-small cell lung cancer.

Key facts

Study ID

NCT00976677

Run by

National Cancer Institute (NCI)

People needed

10

Starts

2010-01-01

Expected to finish

2013-11-01

Last updated by the study team

2014-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Measurable disease as defined by Response Criteria In Solid Tumors (RECIST) criteria
• Baseline measurements and evaluations of all sites of disease must be obtained =< 4 weeks (28 days) prior to randomization
• Eastern Cooperative Oncology Group (ECOG) performance status between 0-1
• No prior chemotherapy for lung cancer; prior chemotherapy for an unrelated condition is allowed if completed > 3 years prior to date of randomization
• Histological or cytologic evidence of non-small cell lung cancer
• Patients must not have any additional active, invasive malignancies requiring therapy
• Patients must have smoked less than or equal to 100 cigarettes in their lifetime
• Stage IV or IIIB (with pleural or pericardial effusion or multifocal pleural involvement) or recurrence after prior curative resection or definitive radiation
• Prior radiation therapy (RT) is allowed, provided RT has ended at least 2 weeks (14 days) prior to date of randomization; patients must have recovered from any adverse events related to the RT (except alopecia and grade 1 neuropathy); no previous irradiation to the only site of measurable disease, unless that site has had subsequent evidence of pathologic or radiologic progression
• Absolute neutrophil count (ANC) >= 1500/mm\^3
• Platelet count >= 100,000/mm\^3
• Bilirubin =< 1.5 mg/dl
• Creatinine =< 2.0 mg/dl
• Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) =< 3 X institutional upper limit of normal (ULN)
• Women must not be pregnant or breast-feeding due to unknown interaction between erlotinib and the developing fetus or newborns potentially exposed to erlotinib by ingestion of lactated milk; all females of childbearing potential must have a blood test within 2 weeks prior to randomization to rule out pregnancy
• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
• Patients must not have clinically significant ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patient must meet the following criteria:
• Non-squamous histology
• No antecedent hemoptysis
• International normalized ratio (INR) =< 3 within 4 weeks (28 days) prior to randomization
• Patients may be on a stable regimen of therapeutic anticoagulation or may be receiving prophylactic anticoagulation of venous access devices, provided that coagulation studies met entry criteria; caution must be exercised for patients requiring anticoagulation, including treatment with low dose heparin or low molecular weight heparin for deep vein thrombosis (DVT) prophylaxis while on study due to an increased risk of bleeding with bevacizumab
• No history of untreated brain metastases NOTE: Recent data (PASSPORT, ATLAS, AIRES) suggest that bevacizumab can be given in patients with treated brain metastases; investigators can use their discretion in deciding whether to use bevacizumab in patients who fulfill these criteria
• Urine dipstick must be =< 0-1+ within 4 weeks (28 days) of randomization. If urine dipstick is > 1+ then the Urine Protein Creatinine (UPC) ratio must be calculated
• Patients must have no history of thrombotic or hemorrhagic disorders

Where it is running

• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Saint Anthony Central Hospital — Denver, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Exempla Saint Joseph Hospital — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Colorado Cancer Research Program CCOP — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Saint Mary Corwin Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
• Saint Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital Association — Canton, Illinois, United States
• Illinois CancerCare-Canton — Canton, Illinois, United States
• Illinois CancerCare-Carthage — Carthage, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• The Medical Center of Aurora — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.