Lung Cancer Clinical Trial

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

Summary

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.

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Full Description

PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival (PFS) of non-smokers with advanced non-small cell lung cancer (NSCLC) randomized to standard of care (either carboplatin/paclitaxel with or without bevacizumab), or standard of care plus erlotinib hydrochloride.

SECONDARY OBJECTIVES:

I. To evaluate the overall survival from day of randomization. II. To evaluate response rate. III. To evaluate relative toxicity. IV. To determine the frequency of epidermal growth factor receptor (EGFR) and Kras mutations in non-smokers with NSCLC and correlate mutation status with response rate and progression free survival.

V. To obtain blood and tissue specimens for further marker-based exploratory analyses regarding EGFR inhibitors.

VI. To evaluate EGFR positivity by fluorescence in situ hybridization (FISH) as a predictor of improved PFS in patients treated with erlotinib hydrochloride.

OUTLINE: This is a multicenter study. Patients are stratified according to gender and eligibility for bevacizumab therapy (ineligible vs eligible and willing to receive bevacizumab vs eligible and not willing to receive bevacizumab). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive placebo orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm I. Patients also receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected for correlative laboratory studies.

After completion of study treatment, patients are followed up periodically for 5 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
Patients with history of hypertension must be well-controlled (blood pressure [BP] =< 150/90 within 4 weeks [28 days] of randomization) and on a stable regimen of anti-hypertensive therapy (within 4 weeks of randomization)
Patients must not have serious non-healing wound ulcer, bone fracture, or major surgical procedure within 28 days prior to randomization
Patients with a known history of myocardial infarction or other evidence of arterial thrombotic disease (angina) will be allowed on study only if they have had no evidence of active disease for at least 6 months prior to randomization
Patients must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to randomization
Patients must not have significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomization

Patients must not have clinically significant cardiovascular disease including:

History of cerebral vascular accident (CVA) within 6 months
New York Heart Association grade II or greater congestive heart failure
Serious and inadequately controlled cardiac arrhythmia
Clinically significant peripheral vascular disease (symptomatic with intermittent claudications or < 6 months from a bypass operation)

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT00976677

Recruitment Status:

Terminated

Sponsor:

National Cancer Institute (NCI)

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There are 79 Locations for this study

See Locations Near You

The Medical Center of Aurora
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs Colorado, 80907, United States
Saint Anthony Central Hospital
Denver Colorado, 80204, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Exempla Saint Joseph Hospital
Denver Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver Colorado, 80218, United States
Rose Medical Center
Denver Colorado, 80220, United States
Colorado Cancer Research Program CCOP
Denver Colorado, 80224, United States
Swedish Medical Center
Englewood Colorado, 80110, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction Colorado, 81502, United States
North Colorado Medical Center
Greeley Colorado, 80631, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Longmont United Hospital
Longmont Colorado, 80501, United States
McKee Medical Center
Loveland Colorado, 80539, United States
Saint Mary Corwin Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge Colorado, 80033, United States
Saint Francis Hospital and Medical Center
Hartford Connecticut, 06105, United States
Illinois CancerCare-Bloomington
Bloomington Illinois, 61701, United States
Saint Joseph Medical Center
Bloomington Illinois, 61701, United States
Graham Hospital Association
Canton Illinois, 61520, United States
Illinois CancerCare-Canton
Canton Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage Illinois, 62321, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Eureka Hospital
Eureka Illinois, 61530, United States
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States
Illinois CancerCare Galesburg
Galesburg Illinois, 61401, United States
Ingalls Memorial Hospital
Harvey Illinois, 60426, United States
Illinois CancerCare-Havana
Havana Illinois, 62644, United States
Mason District Hospital
Havana Illinois, 62644, United States
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States
Mcdonough District Hospital
Macomb Illinois, 61455, United States
Garneau, Stewart C MD (UIA Investigator)
Moline Illinois, 61265, United States
Porubcin, Michael MD (UIA Investigator)
Moline Illinois, 61265, United States
Sharis, Christine M MD (UIA Investigator)
Moline Illinois, 61265, United States
Spector, David MD (UIA Investigator)
Moline Illinois, 61265, United States
Stoffel, Thomas J MD (UIA Investigator)
Moline Illinois, 61265, United States
Trinity Medical Center
Moline Illinois, 61265, United States
Illinois CancerCare-Monmouth
Monmouth Illinois, 61462, United States
Bromenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center Foundation
Normal Illinois, 61761, United States
Illinois CancerCare-Community Cancer Center
Normal Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa Illinois, 61350, United States
Pekin Cancer Treatment Center
Pekin Illinois, 61554, United States
Pekin Hospital
Pekin Illinois, 61554, United States
Illinois CancerCare-Pekin
Pekin Illinois, 61603, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61603, United States
Proctor Hospital
Peoria Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
Illinois Oncology Research Association CCOP
Peoria Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria Illinois, 61637, United States
Illinois CancerCare-Peru
Peru Illinois, 61354, United States
Illinois Valley Hospital
Peru Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
Illinois CancerCare-Spring Valley
Spring Valley Illinois, 61362, United States
McFarland Clinic
Ames Iowa, 50010, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf Iowa, 52722, United States
Cedar Rapids Oncology Association
Cedar Rapids Iowa, 52403, United States
Mercy Hospital
Cedar Rapids Iowa, 52403, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States
Siouxland Hematology Oncology Associates
Sioux City Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City Iowa, 51104, United States
Saint Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor Michigan, 48106, United States
Oakwood Hospital
Dearborn Michigan, 48124, United States
Saint John Hospital and Medical Center
Detroit Michigan, 48236, United States
Hurley Medical Center
Flint Michigan, 48502, United States
Genesys Regional Medical Center-West Flint Campus
Flint Michigan, 48532, United States
Allegiance Health
Jackson Michigan, 49201, United States
Sparrow Hospital
Lansing Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Saint Joseph Mercy Port Huron
Port Huron Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Essentia Health Duluth Clinic CCOP
Duluth Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth Minnesota, 55805, United States
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly New Jersey, 08060, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
Virtua West Jersey Hospital Voorhees
Voorhees New Jersey, 08043, United States
Mercy Medical Center
Canton Ohio, 44708, United States
Aultman Health Foundation
Canton Ohio, 44710, United States
Case Western Reserve University
Cleveland Ohio, 44106, United States
Lake University Ireland Cancer Center
Mentor Ohio, 44060, United States
Southwest General Health Center Ireland Cancer Center
Middleburg Heights Ohio, 44130, United States
UHHS-Chagrin Highlands Medical Center
Orange Village Ohio, 44122, United States
UHHS-Westlake Medical Center
Westlake Ohio, 44145, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazelton
Hazleton Pennsylvania, 18201, United States
Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Abramson Cancer Center of The University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Geisinger Medical Group
State College Pennsylvania, 16801, United States
Geisinger Wyoming Valley
Wilkes-Barre Pennsylvania, 18711, United States
Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Mainline Health CCOP
Wynnewood Pennsylvania, 19096, United States
Parkland Memorial Hospital
Dallas Texas, 75235, United States
Zale Lipshy University Hospital
Dallas Texas, 75235, United States
Saint Paul Hospital
Dallas Texas, 75390, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Dean Hematology and Oncology Clinic
Madison Wisconsin, 53717, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT00976677

Recruitment Status:

Terminated

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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