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Lung AdenocarcinomaPhase 2NCT00126581

Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer

A Phase 2 study testing Carboplatin, Erlotinib and Erlotinib Hydrochloride in people with Lung Adenocarcinoma and Lung Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 96 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Erlotinib and Erlotinib Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
96 sitesUnited States
Study dates
15 Aug 2005to 28 Nov 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic documentation of primary lung adenocarcinoma including any variant thereof such as pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma; patients with non-small cell lung cancer (NSCLC) not otherwise specified (NOS) are not eligible
  • Pathology block or unstained slides from initial or subsequent diagnosis must be available for sequencing of EGFR, K-ras, Erb-2 and B-raf; patients need to have had at least a core biopsy; patients whose diagnosis was made through a fine needle aspirate will not have sufficient material for mutational analysis and are not eligible
  • Select stage IIIB with cytologically documented malignant pleural or pericardial effusion OR stage IV disease
  • Patients must be chemotherapy naïve; they may not have received neo-adjuvant or adjuvant chemotherapy
  • No prior exposure to OSI-774 (erlotinib) or other treatments targeting the human epidermal growth factor receptor (HER) family axis (e.g., trastuzumab, gefitinib, cetuximab, lapatinib, etc.)
  • No uncontrolled central nervous system metastases (i.e., any known central nervous system [CNS] lesion which is radiographically unstable, symptomatic and/or requiring corticosteroids); patients must be >= 3 weeks beyond completing cranial irradiation and off corticosteroid therapy
Show all 27Show fewer
  • >= 3 weeks since prior radiation therapy
  • >= 3 weeks since prior major surgery
  • No treatment with an investigational agent currently or within the last 28 days
  • Non-smoker or former light smoker; non-smoker is defined as a person who smoked =< 100 cigarettes in their lifetime while a former light smoker is a patient who smoked between > 100 cigarettes AND =< 10 pack years AND quit >= 1 year ago; this must be documented on the On-study Form (C-1405)
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Non-pregnant and non-nursing
  • No dysphagia or active gastrointestinal disease or disorder that alters gastrointestinal motility or absorption; no lack of integrity of the gastrointestinal tract (e.g., a significant surgical resection of the stomach or small bowel); patients unable to swallow intact tablets must be able to swallow tablets dissolved in water
  • Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; lesions that are considered non-measurable include the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Granulocyte >= 1,500/mcl
  • Platelet count >= 100,000/mcl
  • Hemoglobin >= 9.0 g/dL
  • Total bilirubin =< upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x ULN
  • Creatinine =< 1.5 mg/dl

Who cannot join

None listed.

Trial locations and contacts

96 sites in 1 country.

96 sites in 1 country

United States96 sites

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Veterans Administration

    Columbia, Missouri, 65201

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mass General/North Shore Cancer Center

    Danvers, Massachusetts, 01923

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Saint Rose Hospital

    Hayward, California, 94545

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Capital Region Medical Center

    Jefferson City, Missouri, 65101

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Rappahannock General Hospital

    Kilmarnock, Virginia, 22482

  • Vidant Oncology-Kinston

    Kinston, North Carolina, 28501

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • AMITA Health Adventist Medical Center

    La Grange, Illinois, 60525

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Northwell Health NCORP

    Lake Success, New York, 11042

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Middlesex Hospital

    Middletown, Connecticut, 06457

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • El Camino Hospital

    Mountain View, California, 94040

  • Saint Joseph Hospital

    Nashua, New Hampshire, 03060

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Ralph Lauren Center for Cancer Care and Prevention

    New York, New York, 10035

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Great Plains Health Callahan Cancer Center

    North Platte, Nebraska, 69101

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Hematology and Oncology Associates-Oakland

    Oakland, California, 94609

  • Tom K Lee Inc

    Oakland, California, 94609

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73120

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Memorial Hospital of Rhode Island

    Pawtucket, Rhode Island, 02860

  • Valley Care Health System - Pleasanton

    Pleasanton, California, 94588

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Lakeland Medical Center Saint Joseph

    Saint Joseph, Michigan, 49085

  • University of California San Diego

    San Diego, California, 92103

  • Kaiser Permanente-San Diego Mission

    San Diego, California, 92108

  • Veterans Administration-San Diego Medical Center

    San Diego, California, 92161

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • Doctors Medical Center- JC Robinson Regional Cancer Center

    San Pablo, California, 94806

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • South Shore Hospital

    South Weymouth, Massachusetts, 02190

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Saint Joseph's Hospital Health Center

    Syracuse, New York, 13203

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wilson Medical Center

    Wilson, North Carolina, 27893

Other trials in United States

About this study

Official title: A Phase II Randomized Study of OSI-774 (Erlotinib) (NSC #718781) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers

This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving either drug alone.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the distribution of progression-free survival (PFS) in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 (erlotinib) (erlotinib hydrochloride) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

SECONDARY OBJECTIVES:

  1. To determine the radiographic response rate in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

II. To determine the frequency of epidermal growth factor receptor (EGFR) and V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) mutations and anaplastic lymphoma kinase (ALK) translocations in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers.

III. To determine the response rate and time to progression in patients with and without EGFR mutations treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

IV. To determine the response rate and time to progression in patients with and without K-ras mutations treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

  1. To determine the median and overall survival of patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

VI. To estimate the response rate, progression-free, and overall survival of patients with echinoderm microtubule associated protein like (EML)4-ALK translocation who received OSI-774 erlotinib alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive erlotinib hydrochloride as in Arm I. Patients also receive paclitaxel intravenously (IV) over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of treatment, patients may continue to receive erlotinib hydrochloride alone as above.

After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for up to 2 years.

Being tested
Carboplatin, Erlotinib, Erlotinib Hydrochloride, Paclitaxel
Keywords
A Phase II Randomized Study of OSI-774
Medical subject headings
Adenocarcinoma of Lung, Pleural Effusion, Malignant, Adenocarcinoma, Bronchiolo-Alveolar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • ErlotinibDrug

    Given PO

  • Erlotinib HydrochlorideDrug

    Also called Cp-358,774, OSI-774, Tarceva

    Given PO

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

Study groups in NCT00126581
Study groupRoleWhat they receive
Arm I (erlotinib hydrochloride)ExperimentalPatients receive erlotinib hydrochloride PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Erlotinib; Drug: Erlotinib Hydrochloride
Arm II (erlotinib hydrochloride, paclitaxel, carboplatin)ExperimentalPatients receive erlotinib hydrochloride as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of treatment, patients may continue to receive erlotinib hydrochloride alone as above.
Receives: Drug: Carboplatin; Drug: Erlotinib; Drug: Erlotinib Hydrochloride; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 18 Weeks Progression Free Survival (PFS) Rate

    The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm.

    The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated.

    Measured: At 18 weeks

Secondary outcomes (2)

  1. Overall Response Rate

    The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.

    Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:

    Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions

    Measured: Duration of Study (up to 3 years)

  2. Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.

    The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.

    Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.

    Measured: Duration of study (up to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2005 (estimated)
  2. Study start15 Aug 2005
  3. Primary completion30 Jun 2010
  4. Study completion28 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00126581
Sponsor's protocol ID
NCI-2009-00464
Other IDs
NCI-2009-00464, CDR0000437097, CALGB-30406, CALGB-30406, U10CA180821, U10CA031946
Status last verified
Jul 2019
First submitted
2 Aug 2005
Last updated
7 Aug 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Erlotinib and Erlotinib Hydrochloride in people with Lung Adenocarcinoma and Lung Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 96 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

18 Weeks Progression Free Survival (PFS) Rate (time frame: At 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00126581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.

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Clinical Trial NCT00126581 | AzTrials