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Lung CancerPhase 2NCT00661193

S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase 2 study testing carboplatin, erlotinib hydrochloride and paclitaxel in people with Lung Cancer, run by SWOG Cancer Research Network at 124 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

RATIONALE: Erlotinib 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 or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, erlotinib hydrochloride and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
124 sitesUnited States
Study dates
Dec 2008to Dec 2016
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following subtypes:
  • Adenocarcinoma
  • Large cell carcinoma
  • Squamous cell carcinoma
  • Unspecified
  • Newly diagnosed primary disease OR recurrent disease after prior surgery and/or radiotherapy, meeting 1 of the following staging criteria:
  • Selected stage IIIB disease (T4 [secondary to malignant pleural effusion only], any N, M0)
  • Stage IV disease (any T, any N, M1 [distant metastases present])
  • Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical exam, or nuclear scan
  • The CT scan from a combined PET/CT scan may only be used to document nonmeasurable disease
  • Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
  • Shows evidence of EGFR tyrosine kinase inhibitor therapy benefit (i.e., "proteomics positive") prior to study registration
  • No untreated brain metastases
  • Patients with treated brain metastases are allowed provided metastases have remained controlled for at least two weeks following treatment, AND patient has no residual neurological dysfunction off corticosteroids
  • Patients with neurologic abnormalities on physical examination or symptoms must have a negative pretreatment CT or MRI scan of the brain 28 days prior to registration

PATIENT CHARACTERISTICS:

  • Zubrod performance status 2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 1,000/mm³
  • Serum bilirubin normal
  • SGOT or SGPT normal
  • Serum creatinine ≤ 2 times upper limit of normal OR creatinine clearance ≥ 50 mL/min
  • Willing to provide prior smoking history as requested on the prestudy form
  • No gastrointestinal (GI) tract disease resulting in an inability to take enteral medication
  • No malabsorption syndrome or requirement for IV alimentation
  • No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
  • No significant history of cardiac disease, including any of the following:
  • Uncontrolled high blood pressure
  • Unstable angina
  • Congestive heart failure
  • Myocardial infarction within the past 6 months
  • Cardiac ventricular arrhythmia requiring medication
  • No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy or surgery (thoracic or other major surgery) and recovered
  • At least 1 year since prior adjuvant chemotherapy
  • No prior systemic hormonal therapy, chemotherapy, or biological therapy for advanced NSCLC
  • No prior EGFR inhibitors
  • No prior surgical procedures affecting absorption
  • No concurrent major surgery

Trial locations and contacts

124 sites in 1 country.

124 sites in 1 country

United States124 sites

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Island Hospital Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Kaiser Permanente - Deer Valley

    Antioch, California, 94531

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, 94704

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Highline Medical Center Cancer Center

    Burien, Washington, 98166

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • St. Rose Ambulatory and Surgery Center

    Great Bend, Kansas, 67530

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Hays Medical Center

    Hays, Kansas, 67601

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Kaiser Permanente - Moanalua Medical Center and Clinic

    Honolulu, Hawaii, 96819

  • Hutchinson Hospital Corporation

    Hutchinson, Kansas, 67502

  • Swedish Medical Center - Issaquah Campus

    Issaquah, Washington, 98029

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kansas City Cancer Centers - West

    Kansas City, Kansas, 66112

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • Kansas City Cancer Centers - South

    Kansas City, Missouri, 64131

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Kansas City Cancer Centers - East

    Lee's Summit, Missouri, 64064

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

    Martinsville, Virginia, 24115

  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP

    Marysville, California, 95901

  • Mountain States Tumor Institute - Meridian

    Meridian, Idaho, 83642

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98274

  • El Camino Hospital Cancer Center

    Mountain View, California, 94040

  • Saint Luke's Mountain States Tumor Institute

    Nampa, Idaho, 83686

  • Sutter Health - Western Division Cancer Research Group

    Novato, California, 94945

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Kaiser Permanente Medical Center - Oakland

    Oakland, California, 94611

  • Epic Care - Oakland

    Oakland, California, 94612

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • Kansas City Cancer Centers - Southwest

    Overland Park, Kansas, 66210

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Mount Carmel Regional Cancer Center

    Pittsburg, Kansas, 66762

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Harrison Poulsbo Hematology and Onocology

    Poulsbo, Washington, 98370

  • Kaiser Permanente Medical Center - Redwood City

    Redwood City, California, 94063

  • Kaiser Permanente Medical Center - Richmond

    Richmond, California, 94801

  • Kaiser Permanente Medical Center - Roseville

    Roseville, California, 95661

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • South Sacramento Kaiser-Permanente Medical Center

    Sacramento, California, 95823

  • Kaiser Permanente Medical Center - Sacramento

    Sacramento, California, 95825

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • Kaiser Permanente Medical Center - San Francisco Geary Campus

    San Francisco, California, 94115

  • California Pacific Medical Center - California Campus

    San Francisco, California, 94118

  • Kaiser Permanente Medical Center - Santa Teresa

    San Jose, California, 95119

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

  • Kaiser Foundation Hospital - San Rafael

    San Rafael, California, 94903

  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus

    Santa Clara, California, 95051

  • Kaiser Permanente Medical Center - Santa Rosa

    Santa Rosa, California, 95403

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Kansas City Cancer Center - Shawnee Mission

    Shawnee Mission, Kansas, 66204

  • Kaiser Permanente Medical Center - South San Francisco

    South San Francisco, California, 94080

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology, PS

    Spokane, Washington, 99218

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Kaiser Permanente Medical Facility - Stockton

    Stockton, California, 95210

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • Veterans Affairs Medical Center - Topeka (O'Neil)

    Topeka, Kansas, 66622

  • Tahoe Forest Cancer Center

    Truckee, California, 96161

  • Mountain States Tumor Institute at St. Luke's

    Twin Falls, Idaho, 83301

  • Kaiser Permanente Medical Center - Vacaville

    Vacaville, California, 95688

  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center

    Valdosta, Georgia, 31602

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • Sutter Solano Medical Center

    Vallejo, California, 94589

  • Kaiser Permanente Medical Center - Walnut Creek

    Walnut Creek, California, 94596

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

Other trials in United States

About this study

Official title: A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Performance Status 2 (PS-2)

RATIONALE: Erlotinib 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 or by stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well erlotinib works when given alone or together with carboplatin and paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To select a regimen (erlotinib hydrochloride with or without carboplatin and paclitaxel) for further testing against standard treatment, based on median progression-free survival for ≥ 3 months, in patients with stage IIIB or IV non-small cell lung cancer with a Zubrod performance status of 2.

Secondary

  • To assess the feasibility of selecting patients for a trial based on central EGFR testing of serum in a cooperative group setting.
  • To evaluate the objective tumor response rates (confirmed and unconfirmed, complete and partial response), in a subset of patients with measurable disease.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

Conditions
Lung Cancer
Being tested
carboplatin, erlotinib hydrochloride, paclitaxel
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

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

Study groups in NCT00661193
Study groupRoleWhat they receive
Arm IActive comparatorPatients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: erlotinib hydrochloride
Arm IIActive comparatorPatients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: carboplatin; Drug: erlotinib hydrochloride; Drug: paclitaxel

What is being measured

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

  1. Selection of One of Two Treatment Regimens (Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel) for Further Study in a Phase III Trial, Based on Median Progression-free Survival for ≥ 3 Months

    Measured: From date of registration to 3 years or death, whichever comes first

Secondary outcomes (1)

  1. Response Rate (Confirmed and Unconfirmed, Complete and Partial Response) in a Subset of Patients With Measurable Disease

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:

    Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: From date of registration to 3 years or death, whichever comes first

Timeline

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

  1. First posted18 Apr 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2015
  4. Study completionDec 2016

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
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00661193
Sponsor's protocol ID
CDR0000593575
Other IDs
S0709, U10CA032102
Status last verified
Feb 2020
First submitted
17 Apr 2008
Last updated
20 Feb 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, erlotinib hydrochloride and paclitaxel in people with Lung Cancer, run by SWOG Cancer Research Network at 124 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?

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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 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 4 Jan 2017). 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?

Selection of One of Two Treatment Regimens (Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel) for Further Study in a Phase III Trial, Based on Median Progression-free Survival for ≥ 3 Months (time frame: From date of registration to 3 years or death, whichever comes first). 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 NCT00661193.

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 20 Feb 2020.

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