NCT00976677|TerminatedPhase 2Results

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

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)

National Cancer Institute (NCI)ClinicalTrials.gov

Compare

5 other identifiers

NCI-2011-01967ECOG-E2508CDR0000654212E2508U10CA021115

Study Type

interventional

Target

Locations

1 country

Sites

108

Timeline

RegisteredSep 2009

StartedJan 2010

CompletionNov 2013

Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jan 2010

Typical duration for phase_2

Geographic Reach

1 country

108 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

First Submitted

Initial submission to the registry

September 11, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed

4 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 22, 2013

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed

Last Updated

May 30, 2014

Status Verified

December 1, 2013

Enrollment Period

2.5 years

First QC Date

September 11, 2009

Results QC Date

April 24, 2013

Last Update Submit

May 23, 2014

Conditions

Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Progression-free Survival (PFS)
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.
Every 6 weeks during treatment and every 3 months in follow-up until disease progression or up to 5 years

Study Arms (2)

Arm I

ACTIVE COMPARATOR

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: paclitaxelDrug: carboplatinBiological: bevacizumab

Arm II

EXPERIMENTAL

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 hydrochlorideDrug: paclitaxelDrug: carboplatinBiological: bevacizumab

Interventions

erlotinib hydrochlorideDRUG

Given PO

Also known as: CP-358,774, erlotinib, OSI-774

Arm II

paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol

Arm IArm II

carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Arm IArm II

bevacizumabBIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Arm IArm II

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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
+20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (108)

The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

Saint Anthony Central Hospital

Denver, Colorado, 80204, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Exempla Saint Joseph Hospital

Denver, Colorado, 80218, United States

Location

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

Colorado Cancer Research Program CCOP

Denver, Colorado, 80224-2522, United States

Location

Swedish Medical Center

Englewood, Colorado, 80110, United States

Location

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81502, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States

Location

North Suburban Medical Center

Thornton, Colorado, 80229, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61701, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital Association

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare Galesburg

Galesburg, Illinois, 61401, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Illinois CancerCare-Havana

Havana, Illinois, 62644, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Mcdonough District Hospital

Macomb, Illinois, 61455, United States

Location

Garneau, Stewart C MD (UIA Investigator)