AzTrials
AzTrials

Colorectal CancerPhase 2NCT00056030

Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases From Colorectal Cancer

A Phase 2 study testing cetuximab, fluorouracil and leucovorin calcium in people with Colorectal Cancer and Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 162 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Metastatic Cancer
What is being tested?
cetuximab, fluorouracil and leucovorin calcium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
162 sitesUnited States
Study dates
Dec 2004to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

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

DISEASE CHARACTERISTICS:

  • History of completely resected primary adenocarcinoma of the colon or rectum
  • No gross or microscopic evidence of residual disease
  • Liver metastases, meeting 1 of the following criteria:
  • Not optimally resectable
  • Requires resection of all 3 major hepatic veins, the portal vein bifurcation, or the retrohepatic vena cava
  • Includes the main right or main left portal vein and the main hepatic vein of the opposite lobe
  • Requires more than a right or left trisegmentectomy
  • At least 6 metastatic lesions distributed diffusely in both lobes of the liver
  • Measurable disease
  • At least 1 measurable lesion ≥ 20 mm
  • No evidence of extrahepatic metastases by physical examination or x-ray
  • No previously resected extrahepatic metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • AST ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ ULN
  • No preexisting chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that would preclude surgical resection of metastases

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No clinical evidence of congestive heart failure
  • No New York Heart Association class III-IV heart disease
  • No significant cardiac disease
  • No uncontrolled hypertension
  • No unstable angina
  • No congestive heart failure
  • No uncontrolled arrhythmias

Gastrointestinal

  • Adequate oral nutrition with estimated caloric intake of ≥ 1,500 calories/day
  • No severe anorexia or frequent nausea and/or vomiting
  • No history of gastrointestinal bleeding that has not been appropriately addressed

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to tolerate major surgery
  • No prior allergic reaction or known sensitivity to chimerized or murine monoclonal antibody therapy
  • No documented presence of human anti-mouse antibodies
  • No known allergy to other platinum compounds
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ, or tumors associated with less than 10% probability of death within 5 years of diagnosis
  • No preexisting neuropathy ≥ grade 2
  • No symptomatic pulmonary fibrosis or interstitial pneumonitis
  • No uncontrolled bacterial or viral infection
  • HIV negative
  • No fungal infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No colony-stimulating factors within 24 hours of day 1 of each course
  • No concurrent immunotherapy

Chemotherapy

  • At least 1 year since prior adjuvant systemic fluorouracil with or without levamisole or with or without leucovorin calcium
  • No prior oxaliplatin
  • No prior systemic chemotherapy for metastatic disease
  • No prior chemoembolization for metastatic disease
  • No prior hepatic artery infusion chemotherapy for metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 12 months since prior adjuvant radiotherapy
  • Prior radiofrequency ablation allowed
  • No prior radiotherapy to the liver
  • No prior radiotherapy to more than 25% of the bone marrow
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • More than 21 days since prior abdominal exploration (with or without intestinal resection)

Other

  • No prior anti-EGFR-directed therapy
  • Prior cryotherapy allowed
  • No oral cryotherapy on day 1 of each course

Trial locations and contacts

162 sites in 1 country.

162 sites in 1 country

United States162 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Study site

    Alexandria, Minnesota, 56308

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • Study site

    Bettendorf, Iowa, 52722

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Graham Hospital

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-0001

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • 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

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Broadway

    Fargo, North Dakota, 58122

  • Study site

    Fergus Falls, Minnesota, 56537

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Mason District Hospital

    Havana, Illinois, 62644

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Meeker County Memorial Hospital

    Lichfield, Minnesota, 55355

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Trinity Medical Center - East

    Moline, Illinois, 61265

  • Study site

    Moline, Illinois, 61265

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Chippewa County - Montevideo Hospital and Medical Center

    Montevideo, Minnesota, 56265

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Reid Hospital & Health Care Services, Incorporated

    Richmond, Indiana, 47374

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

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • 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

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Guthrie Cancer Center at Guthrie Clinic Sayre

    Sayre, Pennsylvania, 18840

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • 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

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • 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

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • 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

  • HealthEast Cancer Care at Woodwinds Health Campus

    Woodbury, Minnesota, 55125

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: A Phase II Study Of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), Leucovorin (CF), and Cetuximab (C225) For Patients With Unresectable Hepatic Metastases From Metastatic Adenocarcinoma Of The Colon Or Rectum

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with cetuximab works in treating patients with unresectable liver metastases from colorectal cancer.

Read the detailed description

OBJECTIVES:

  • Determine the surgical resectability rate of patients with unresectable hepatic metastases secondary to metastatic colorectal adenocarcinoma treated with oxaliplatin, fluorouracil, leucovorin calcium, and cetuximab.
  • Determine the response rate and overall survival of patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease.

Quality of life is assessed at baseline and prior to each treatment course.

Patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 67-73 patients will be accrued for this study within 4 years.

Keywords
liver metastases, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

Study groups in NCT00056030
Study groupRoleWhat they receive
cetuximab + oxaliplatin + leucovorin + fluorouracilExperimentalPatients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease. Quality of life is assessed at baseline and prior to each treatment course. Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
Receives: Biological: cetuximab; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin

What is being measured

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

  1. Surgical resectability rate as assessed by surgical resection of liver metastases

    Measured: Up to 4 years

Secondary outcomes (3)

  1. Response rate as measured by RECIST criteria every 6 weeks

    Measured: Up to 4 years

  2. Overall survival

    Measured: Up to 4 years

  3. Quality of life as assessed by UNISCALE and Symptom Distress Scale every 6 weeks

    Measured: Up to 4 years

Timeline

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

  1. First posted7 Mar 2003 (estimated)
  2. Study startDec 2004
  3. Primary completionOct 2007

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
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00056030
Sponsor's protocol ID
NCCTG-N014A
Other IDs
NCI-2012-02521, CDR0000271923
Status last verified
Jan 2017
First submitted
6 Mar 2003
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab, fluorouracil and leucovorin calcium in people with Colorectal Cancer and Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 162 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Surgical resectability rate as assessed by surgical resection of liver metastases (time frame: Up to 4 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 NCT00056030.

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 24 Jan 2017.

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