Carboplatin, Paclitaxel, and Bevacizumab With or Without Erlotinib Hydrochloride in Treating Non-Smokers With Advanced Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00976677 |
Recruitment Status
:
Terminated
First Posted
: September 14, 2009
Results First Posted
: July 22, 2013
Last Update Posted
: May 30, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer | Drug: erlotinib hydrochloride Drug: paclitaxel Drug: carboplatin Biological: bevacizumab | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized Double-Blind Placebo Controlled Phase II Trial Evaluating Erlotinib in Non-Smoking Patients With (Bevacizumab-Eligible and Ineligible) Advanced Non-Small Cell Lung Cancer (NSCLC) |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Arm I
Patients receive paclitaxel 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 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 placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
|
Drug: paclitaxel
Given IV
Other Names:
Drug: carboplatin
Given IV
Other Names:
Biological: bevacizumab
Given IV
Other Names:
|
Experimental: 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.
|
Drug: erlotinib hydrochloride
Given PO
Other Names:
Drug: paclitaxel
Given IV
Other Names:
Drug: carboplatin
Given IV
Other Names:
Biological: bevacizumab
Given IV
Other Names:
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- Progression-free Survival (PFS) [ Time Frame: Every 6 weeks during treatment and every 3 months in follow-up until disease progression or up to 5 years ]Progression-free survival (PFS) is defined to be the time from randomization to progression of disease or death, whichever occurs first. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976677

United States, Colorado | |
The Medical Center of Aurora | |
Aurora, Colorado, United States, 80012 | |
Boulder Community Hospital | |
Boulder, Colorado, United States, 80301 | |
Penrose-Saint Francis Healthcare | |
Colorado Springs, Colorado, United States, 80907 | |
Saint Anthony Central Hospital | |
Denver, Colorado, United States, 80204 | |
Porter Adventist Hospital | |
Denver, Colorado, United States, 80210 | |
Exempla Saint Joseph Hospital | |
Denver, Colorado, United States, 80218 | |
Presbyterian - Saint Lukes Medical Center - Health One | |
Denver, Colorado, United States, 80218 | |
Rose Medical Center | |
Denver, Colorado, United States, 80220 | |
Colorado Cancer Research Program CCOP | |
Denver, Colorado, United States, 80224-2522 | |
Swedish Medical Center | |
Englewood, Colorado, United States, 80110 | |
Saint Mary's Hospital and Regional Medical Center | |
Grand Junction, Colorado, United States, 81502 | |
North Colorado Medical Center | |
Greeley, Colorado, United States, 80631 | |
Sky Ridge Medical Center | |
Lone Tree, Colorado, United States, 80124 | |
Longmont United Hospital | |
Longmont, Colorado, United States, 80501 | |
McKee Medical Center | |
Loveland, Colorado, United States, 80539 | |
Saint Mary Corwin Medical Center | |
Pueblo, Colorado, United States, 81004 | |
North Suburban Medical Center | |
Thornton, Colorado, United States, 80229 | |
Exempla Lutheran Medical Center | |
Wheat Ridge, Colorado, United States, 80033 | |
United States, Connecticut | |
Saint Francis Hospital and Medical Center | |
Hartford, Connecticut, United States, 06105 | |
United States, Illinois | |
Illinois CancerCare-Bloomington | |
Bloomington, Illinois, United States, 61701 | |
Saint Joseph Medical Center | |
Bloomington, Illinois, United States, 61701 | |
Graham Hospital Association | |
Canton, Illinois, United States, 61520 | |
Illinois CancerCare-Canton | |
Canton, Illinois, United States, 61520 | |
Illinois CancerCare-Carthage | |
Carthage, Illinois, United States, 62321 | |
Memorial Hospital | |
Carthage, Illinois, United States, 62321 | |
Eureka Hospital | |
Eureka, Illinois, United States, 61530 | |
Illinois CancerCare-Eureka | |
Eureka, Illinois, United States, 61530 | |
Illinois CancerCare Galesburg | |
Galesburg, Illinois, United States, 61401 | |
Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
Illinois CancerCare-Havana | |
Havana, Illinois, United States, 62644 | |
Mason District Hospital | |
Havana, Illinois, United States, 62644 | |
Illinois CancerCare-Kewanee Clinic | |
Kewanee, Illinois, United States, 61443 | |
Illinois CancerCare-Macomb | |
Macomb, Illinois, United States, 61455 | |
Mcdonough District Hospital | |
Macomb, Illinois, United States, 61455 | |
Garneau, Stewart C MD (UIA Investigator) | |
Moline, Illinois, United States, 61265 | |
Porubcin, Michael MD (UIA Investigator) | |
Moline, Illinois, United States, 61265 | |
Sharis, Christine M MD (UIA Investigator) | |
Moline, Illinois, United States, 61265 | |
Spector, David MD (UIA Investigator) | |
Moline, Illinois, United States, 61265 | |
Stoffel, Thomas J MD (UIA Investigator) | |
Moline, Illinois, United States, 61265 | |
Trinity Medical Center | |
Moline, Illinois, United States, 61265 | |
Illinois CancerCare-Monmouth | |
Monmouth, Illinois, United States, 61462 | |
Bromenn Regional Medical Center | |
Normal, Illinois, United States, 61761 | |
Community Cancer Center Foundation | |
Normal, Illinois, United States, 61761 | |
Illinois CancerCare-Community Cancer Center | |
Normal, Illinois, United States, 61761 | |
Illinois CancerCare-Ottawa Clinic | |
Ottawa, Illinois, United States, 61350 | |
Ottawa Regional Hospital and Healthcare Center | |
Ottawa, Illinois, United States, 61350 | |
Pekin Cancer Treatment Center | |
Pekin, Illinois, United States, 61554 | |
Pekin Hospital | |
Pekin, Illinois, United States, 61554 | |
Illinois CancerCare-Pekin | |
Pekin, Illinois, United States, 61603 | |
Methodist Medical Center of Illinois | |
Peoria, Illinois, United States, 61603 | |
Proctor Hospital | |
Peoria, Illinois, United States, 61614 | |
Illinois CancerCare-Peoria | |
Peoria, Illinois, United States, 61615 | |
Illinois Oncology Research Association CCOP | |
Peoria, Illinois, United States, 61615 | |
OSF Saint Francis Medical Center | |
Peoria, Illinois, United States, 61637 | |
Illinois CancerCare-Peru | |
Peru, Illinois, United States, 61354 | |
Illinois Valley Hospital | |
Peru, Illinois, United States, 61354 | |
Illinois CancerCare-Princeton | |
Princeton, Illinois, United States, 61356 | |
Perry Memorial Hospital | |
Princeton, Illinois, United States, 61356 | |
Illinois CancerCare-Spring Valley | |
Spring Valley, Illinois, United States, 61362 | |
United States, Iowa | |
McFarland Clinic | |
Ames, Iowa, United States, 50010 | |
Constantinou, Costas L MD (UIA Investigator) | |
Bettendorf, Iowa, United States, 52722 | |
Cedar Rapids Oncology Association | |
Cedar Rapids, Iowa, United States, 52403 | |
Mercy Hospital | |
Cedar Rapids, Iowa, United States, 52403 | |
Oncology Associates at Mercy Medical Center | |
Cedar Rapids, Iowa, United States, 52403 | |
Siouxland Hematology Oncology Associates | |
Sioux City, Iowa, United States, 51101 | |
Mercy Medical Center-Sioux City | |
Sioux City, Iowa, United States, 51104 | |
Saint Luke's Regional Medical Center | |
Sioux City, Iowa, United States, 51104 | |
United States, Maryland | |
Greater Baltimore Medical Center | |
Baltimore, Maryland, United States, 21204 | |
United States, Michigan | |
Saint Joseph Mercy Hospital | |
Ann Arbor, Michigan, United States, 48106-0995 | |
Michigan Cancer Research Consortium Community Clinical Oncology Program | |
Ann Arbor, Michigan, United States, 48106 | |
Oakwood Hospital | |
Dearborn, Michigan, United States, 48124 | |
Saint John Hospital and Medical Center | |
Detroit, Michigan, United States, 48236 | |
Hurley Medical Center | |
Flint, Michigan, United States, 48502 | |
Genesys Regional Medical Center-West Flint Campus | |
Flint, Michigan, United States, 48532 | |
Allegiance Health | |
Jackson, Michigan, United States, 49201 | |
Sparrow Hospital | |
Lansing, Michigan, United States, 48912 | |
Saint Mary Mercy Hospital | |
Livonia, Michigan, United States, 48154 | |
Saint Joseph Mercy Oakland | |
Pontiac, Michigan, United States, 48341-2985 | |
Saint Joseph Mercy Port Huron | |
Port Huron, Michigan, United States, 48060 | |
Saint Mary's of Michigan | |
Saginaw, Michigan, United States, 48601 | |
Saint John Macomb-Oakland Hospital | |
Warren, Michigan, United States, 48093 | |
United States, Minnesota | |
Essentia Health Duluth Clinic CCOP | |
Duluth, Minnesota, United States, 55805 | |
Essentia Health Saint Mary's Medical Center | |
Duluth, Minnesota, United States, 55805 | |
Miller-Dwan Hospital | |
Duluth, Minnesota, United States, 55805 | |
United States, New Jersey | |
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | |
Mount Holly, New Jersey, United States, 08060 | |
Newark Beth Israel Medical Center | |
Newark, New Jersey, United States, 07112 | |
Virtua West Jersey Hospital Voorhees | |
Voorhees, New Jersey, United States, 08043 | |
United States, Ohio | |
Mercy Medical Center | |
Canton, Ohio, United States, 44708 | |
Aultman Health Foundation | |
Canton, Ohio, United States, 44710 | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 | |
Lake University Ireland Cancer Center | |
Mentor, Ohio, United States, 44060 | |
Southwest General Health Center Ireland Cancer Center | |
Middleburg Heights, Ohio, United States, 44130 | |
UHHS-Chagrin Highlands Medical Center | |
Orange Village, Ohio, United States, 44122 | |
UHHS-Westlake Medical Center | |
Westlake, Ohio, United States, 44145 | |
United States, Pennsylvania | |
Bryn Mawr Hospital | |
Bryn Mawr, Pennsylvania, United States, 19010 | |
Geisinger Medical Center | |
Danville, Pennsylvania, United States, 17822-2001 | |
Geisinger Medical Center-Cancer Center Hazelton | |
Hazleton, Pennsylvania, United States, 18201 | |
Paoli Memorial Hospital | |
Paoli, Pennsylvania, United States, 19301 | |
Abramson Cancer Center of The University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Geisinger Medical Group | |
State College, Pennsylvania, United States, 16801 | |
Geisinger Wyoming Valley | |
Wilkes-Barre, Pennsylvania, United States, 18711 | |
Lankenau Hospital | |
Wynnewood, Pennsylvania, United States, 19096 | |
Mainline Health CCOP | |
Wynnewood, Pennsylvania, United States, 19096 | |
United States, Texas | |
Parkland Memorial Hospital | |
Dallas, Texas, United States, 75235 | |
Zale Lipshy University Hospital | |
Dallas, Texas, United States, 75235 | |
Saint Paul Hospital | |
Dallas, Texas, United States, 75390 | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75390 | |
United States, Wisconsin | |
Dean Hematology and Oncology Clinic | |
Madison, Wisconsin, United States, 53717 |
Principal Investigator: | Corey Langer | Eastern Cooperative Oncology Group |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00976677 History of Changes |
Other Study ID Numbers: |
NCI-2011-01967 NCI-2011-01967 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) ECOG-E2508 CDR0000654212 E2508 ( Other Identifier: Eastern Cooperative Oncology Group ) E2508 ( Other Identifier: CTEP ) U10CA021115 ( U.S. NIH Grant/Contract ) |
First Posted: | September 14, 2009 Key Record Dates |
Results First Posted: | July 22, 2013 |
Last Update Posted: | May 30, 2014 |
Last Verified: | December 2013 |
Additional relevant MeSH terms:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel Albumin-Bound Paclitaxel Bevacizumab Carboplatin Erlotinib Hydrochloride |
Antibodies Immunoglobulins Antibodies, Monoclonal Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Immunologic Factors |