AzTrials
AzTrials

Lung CancerPhase 2NCT00103207

Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer

A Phase 2 study testing cetuximab in people with Lung Cancer, run by Eastern Cooperative Oncology Group at 157 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: Monoclonal antibodies, such as cetuximab, 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
157 sitesUnited States
Study dates
13 Oct 2005to Aug 2012
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

  • Histologically or cytologically confirmed bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features meeting 1 of the following stage criteria:
  • Stage IIIB disease (with pleural or pericardial effusion)
  • Stage IV disease
  • Recurrent disease
  • Measurable disease
  • Tumor tissue available from biopsy
Show all 24Show fewer
  • Age of 18 and over
  • ECOG performance status of 0-2
  • Life expectancy greater than 3 months
  • White blood cell (WBC) ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin normal
  • Aspartate aminotransferase (AST) and/or alanine aminotranferease (ALT) ≤ 2.5 times upper limit of normal
  • Creatinine normal OR Creatinine clearance ≥ 60 mL/min
  • No more than 1 prior chemotherapy regimen for advanced BAC
  • More than 3 years since prior chemotherapy for other malignancies
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for this malignancy and recovered
  • HIV-positive patients are eligible provided the following criteria are met:
  • CD4 count ≥ 100/mm^3
  • Undetectable viral load within the past 3 months
  • Receiving a stable antiretroviral regimen for ≥ 4 weeks before study entry
  • Fertile patients must use effective contraception
  • At least 2 weeks since prior radiotherapy and recovered

Who cannot join

  • Untreated brain metastases
  • Patients with stable brain metastases ≥ 4 weeks after external beam radiotherapy to the brain are eligible
  • Acute hepatitis
  • Symptomatic congestive heart failure
  • Uncontrolled hypertension
  • Unstable angina pectoris
Show all 18Show fewer
  • Cardiac arrhythmia
  • Pregnant or nursing
  • Prior allergic reaction to chimerized or murine monoclonal antibody therapy
  • Documented presence of human anti-mouse antibodies
  • Ongoing or active infection
  • Psychiatric illness or social situation that would preclude study compliance
  • Other uncontrolled illness
  • Prior cetuximab
  • Concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Other prior known epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib)
  • Other concurrent investigational agents
  • Other concurrent anticancer therapy

Trial locations and contacts

157 sites in 1 country.

157 sites in 1 country

United States157 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • St. Luke's Cancer Network at St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus

    Boca Raton, Florida, 33486

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80224-2522

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • Center for Cancer Treatment & Prevention at Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Hunterdon Regional Cancer Center at Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • North Colorado Medical Center

    Greeley, Colorado, 80631

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

    Grosse Pointe Woods, Michigan, 48236

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80502

  • McKee Medical Center

    Loveland, Colorado, 80539

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • St. Mary - Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • St. Joseph Medical Center

    Reading, Pennsylvania, 19604

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Booker Cancer Center at Riverview Medical Center

    Red Bank, New Jersey, 07701

  • Ministry Medical Group at Saint Mary's Hospital

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Swedish-American Regional Cancer Center

    Rockford, Illinois, 61104-2315

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • HealthEast Cancer Care at St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • Hematology and Oncology Associates of Northeastern Pennsylvania

    Scranton, Pennsylvania, 18510

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16803

  • Saint Michael's Hospital Cancer Center

    Stevens Point, Wisconsin, 54481

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • Morton Hospital & Medical Center

    Taunton, Massachusetts, 02780

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Marshfield Clinic - Wausau Center

    Wausau, Wisconsin, 54401

  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • HealthEast Cancer Care at Woodwinds Health Campus

    Woodbury, Minnesota, 55125

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

  • CCOP - Main Line Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features

RATIONALE: Monoclonal antibodies, such as cetuximab, 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.

PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with recurrent or stage IIIB or stage IV lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with recurrent or stage IIIB or IV bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features treated with cetuximab.

Secondary

  • Determine the overall survival and time to progression in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.
  • Correlate expression of total and phosphorylated epidermal growth factor receptor (EGFR), total and phosphorylated AKT3, and total and phosphorylated MAPKinase with response in patients treated with this drug.
  • Determine whether the presence of polymorphisms or mutations in the EGFR gene influences response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours once on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

ACTUAL ACCRUAL: A total of 72 patients were accrued for this study.

Conditions
Lung Cancer
Being tested
cetuximab
Keywords
bronchioalveolar carcinoma (BAC), adenocarcinoma with BAC features, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, cetuximab
Medical subject headings
Lung Neoplasms, Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Non-Small-Cell Lung

What participants receive

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

Study groups in NCT00103207
Study groupRoleWhat they receive
CetuximabExperimentalCetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.
Receives: Biological: cetuximab

What is being measured

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

  1. Objective Response Rate (Proportion of Patients With Objective Response)

    Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.

    Measured: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years

Secondary outcomes (4)

  1. Overall Survival

    Overall survival is defined as the time from registration to death.

    Measured: Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years

  2. Time to Progression

    Time to progression is defined as time from study entry until disease progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.

    Measured: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years

  3. Overall Survival by Smoking Status

    Medians of overall survival by smoking status are reported.

    Measured: Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline

  4. Time to Progression by Smoking Status

    Medians of time to progression by smoking status are reported.

    Measured: Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline

Timeline

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

  1. First posted8 Feb 2005 (estimated)
  2. Study start13 Oct 2005
  3. Primary completionApr 2010
  4. Study completionAug 2012

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00103207
Sponsor's protocol ID
CDR0000409755
Other IDs
U10CA021115, E1504
Status last verified
Jun 2023
First submitted
7 Feb 2005
Last updated
28 Jun 2023
Data monitoring committee
No

Publications

  • Ramalingam SS, Lee JW, Belani CP, Aisner SC, Kolesar J, Howe C, Velasco MR, Schiller JH. Cetuximab for the treatment of advanced bronchioloalveolar carcinoma (BAC): an Eastern Cooperative Oncology Group phase II study (ECOG 1504). J Clin Oncol. 2011 May 1;29(13):1709-14. doi: 10.1200/JCO.2010.33.4094. Epub 2011 Mar 21.

    PubMed 21422434

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab in people with Lung Cancer, run by Eastern Cooperative Oncology Group at 157 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 24 inclusion and 18 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 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 2013). 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?

Objective Response Rate (Proportion of Patients With Objective Response) (time frame: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years). 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 NCT00103207, which also lists 1 linked publication.

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 28 Jun 2023.

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