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AzTrials

Non-Small Cell Lung CancerPhase 3ATRACT-1NCT00662597

ASA404 or Placebo in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Stage IIIb/IV Non-Small Cell Lung Cancer

A Phase 3 study testing ASA404, carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 248 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to determine if adding ASA404 to standard chemotherapy makes the cancer treatment more effective in patients with advanced lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
ASA404, carboplatin and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,285 participants
Where
248 sitesin 26 countries
Study dates
Apr 2008to May 2010
Phase
Phase 3
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

Who may be able to join

  • Histologically confirmed non-small cell carcinoma of the lung. (Histological or cytological specimens must be collected via surgical biopsy, brushing, washing or core needle aspiration of a defined lesion. Sputum cytology is not acceptable.)
  • Newly diagnosed Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease
  • No prior systemic antineoplastic treatment for Stage IIIb/IV non-small cell carcinoma of the lung (Prior neoadjuvant or adjuvant chemotherapy for earlier stage I/II NSCLC is allowed if 12 months or more prior to Baseline visit.)
  • Age ≥ 18 years old
  • WHO Performance Status of 0-1
  • Measurable or non-measurable disease per RECIST criteria (Post-text supplement 1)
Show all 18Show fewer
  • Lab values within the range, as defined below, within 2 weeks of randomization:
  • Absolute neutrophils count (ANC) > 2.0 x 109/L
  • Platelets ≥ 100 x109/L
  • Hemoglobin ≥ 10 g/dL
  • Serum creatinine ≤ 1.5 x ULN (≤ 120 micro mol/L)
  • Serum bilirubin ≤ 1.5 x ULN (≤ 25 micro mol/L)
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases)
  • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x IULN (Sections 6.9.1 and 7.3.4.2)
  • Electrolyte values (potassium, calcium, magnesium) within > 1 x LLN and < 1 x ULN. Patients with corrected electrolyte values are eligible. See Sections 6.8.1 and 7.3.4.3.
  • Females of child-bearing potential must have negative serum pregnancy test (confirmation of negative urine pregnancy test within 72 hours prior to initial dosing).
  • Life expectancy ≥ 12 weeks
  • Written informed consent obtained according to local guidelines

Who cannot join

  • Patients having CNS metastases (Patients having any clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS metastases in order to be eligible for study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed.).
  • Patients with a history of another primary malignancy ≤ 5 years, with the exception of non-melanoma skin cancer or cervical cancer in situ.
  • Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
  • Major surgery ≤ 4 weeks prior to randomization or minor surgery ≤ 2 weeks prior to randomization.(Major surgery is defined by the use of general anesthesia however, endoscopic examinations with diagnostic intent are not considered major surgery. Insertion of a vascular access device is exempt from this exclusion criteria. Patients must have recovered from all surgery-related complications.
  • Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to randomization
  • Prior exposure to Tumor-VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF receptor agents, anti-EGFR agents [bevacizumab, cetuximab, etc.])
Show all 30Show fewer
  • Pleural effusion that causes ≥ CTC grade 2 dyspnea
  • Patients with systolic BP > 160 mm Hg and/or diastolic BP >90 mm Hg
  • Patients with recent hemoptysis associated with NSCLC (> 1 teaspoon in a single episode within 4 weeks)
  • Patients with any one of the following:
  • Patients with long QT syndrome
  • Patients with a Baseline 12-lead ECG QTc of > 450 msec per central evaluation
  • Congestive heart failure (NY Heart Association class III or IV)
  • Patients with a myocardial infarction within 12 months of study entry
  • Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
  • History of labile hypertension or poor compliance with anti-hypertensive regimen
  • History of a sustained ventricular tachycardia
  • Any history of ventricular fibrillation or Torsades de Pointes
  • Right bundle branch block and left anterior hemiblock (bifasicular block)
  • Bradycardia defined as heart rate < 50 beats per minute
  • Concomitant use of drugs with a risk of causing Torsades de Pointes (See Table 6-3)
  • Known allergy or hypersensitivity to platinum-containing drugs, taxanes, other drugs formulated in Cremophor EL (polyoxyethylated castor oil) or any known excipients of these drugs.
  • Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
  • Pregnant or breast feeding females
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
  • Women of child bearing potential or sexually active males, unwilling or unable to use the required highly effective method(s) of contraception for both sexes while receiving treatment and for at least 6 months after the discontinuation of study treatment. (Adequate forms of contraception include IUD, oral or depot contraceptive or the barrier method plus spermicide.)
  • Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions while taking paclitaxel and therefore are not considered effective contraceptive methods for this study when used as a single agent. Therefore, it is highly recommended that a concomitant barrier method be used with oral, implantable, or injectable contraceptives. The investigator shall counsel the patient accordingly. Women of childbearing potential must have a negative pregnancy test (serum or urine) 72 hours prior to administration of study treatment. For a list of substrates of human liver microsomal P450 enzymes, visit website (http://medicine.iupui.edu/flockhart/)
  • Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, chronic liver disease, confirmed diagnosis of HIV infection or active uncontrolled infection).
  • Significant neurologic or psychiatric disorder which could compromise participation in the study Patient unwilling or unable to comply with the protocol
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

248 sites in 26 countries.

248 sites in 26 countries

United States100 sites

  • Akron City Hospital

    Akron, Ohio, 44309-2090

  • Texas Oncology Cancer Center of the High Plains

    Amarillo, Texas, 79106

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • St. Agnes Cancer Center

    Baltimore, Maryland, 21129-5299

  • Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer Institute

    Baltimore, Maryland, 21215-5271

  • The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar Health

    Baltimore, Maryland, 21237

  • Highlands Oncology Group

    Bentonville, Arkansas, 72712

  • Alta Bates Summit Medical Center

    Berkeley, California, 94704

  • Billings Clinic

    Billings, Montana, 59107-7000

  • Boston VA Healthcare System

    Boston, Massachusetts, 02130

  • Palm Beach Institute of Hematology & Oncology

    Boynton Beach, Florida, 33435

  • Florida Cancer Specialists

    Bradenton, Florida, 34209

  • Highline Medical Oncology

    Burien, Washington, 98166

  • Alamance Regional Medical Center-Cancer Ctr.

    Burlington, North Carolina, 27215

  • Patient's Comprehensive Cancer Center

    Carrollton, Texas, 75010

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37804

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Oncology Hematology Care Research

    Cincinnati, Ohio, 45242

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Kootenai Cancer Center (ACORN)

    Coeur d'Alene, Idaho, 83814

  • South Carolina Oncology Associate

    Columbia, South Carolina, 29210

  • South Texas Cancer Institute

    Corpus Christi, Texas, 78405

  • Cancer Care Centers of South Texas

    Dallas, Texas, 75204

  • Texas Oncology at Presbyterian Hospital

    Dallas, Texas, 75231

  • University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390-9179

  • Danville Hematology & Oncology

    Danville, Virginia, 24541

  • Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology Program

    Dayton, Ohio, 45429

  • Medical Oncology Hematology Associates, Inc.

    Dayton, Ohio, 45429

  • St. Luke's Hospital - St Luke's Cancer Center

    Duluth, Minnesota, 55811

  • Pacific Oncology and Hematology Association

    Encinitas, California, 92024

  • Providence Everett Medical Center/Providence regional Cancer Partnership

    Everett, Washington, 98201

  • Medical Oncology & Hematology Associates of Northern Virginia

    Fairfax, Virginia, 22031

  • Carolina Cancer Mgmt/Cape Fear Valley Health System/Med Onc

    Fayetteville, North Carolina, 28304

  • Ft. Wayne Oncology and Hematology

    Fort Wayne, Indiana, 46815

  • Cancer Care Associates

    Fresno, California, 93720

  • Texas Oncology at Garland

    Garland, Texas, 75042

  • Ronald Yanagihara - Private Practice

    Gilroy, California, 95020

  • Sletten Cancer Institute

    Great Falls, Montana, 59405

  • California Cancer Care

    Greenbrae, California, 94904

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Kansas City Veterans Affair Medical Center

    Kansas City, Missouri, 64128

  • Moores UCSD Cancer Center

    La Jolla, California, 92093-0698

  • Arena Oncology Associates

    Lake Success, New York, 11042

  • Breslin Cancer Center

    Lansing, Michigan, 48910

  • New York Oncology Hematology

    Latham, New York, 12210

  • Cleo Craig Memorial Cancer Ctr. & Research Clinic

    Lawton, Oklahoma, 73505

  • Cancer Centers of Central Florida, PA

    Leesburg, Florida, 34788

  • Loma Linda University Cancer Center

    Loma Linda, California, 92354-3834

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • University of Louisville - James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Northwest Georgia Oncology Centers

    Marietta, Georgia, 30060

  • Illinois Oncology/Warren Billhartz Cancer Ctr.

    Maryville, Illinois, 62062

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • The West Clinic

    Memphis, Tennessee, 38120

  • Hematology Oncology Specialists

    Metairie, Louisiana, 70006

  • Advanced Medical Specialties (ACORN)

    Miami, Florida, 33176

  • Medical Consultants

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin/Division of Neoplastic & Related Disorders

    Milwaukee, Wisconsin, 53226

  • University of South Alabama/Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Lowcountry Hematology & Oncology PA

    Mt. Pleasant, South Carolina, 29464

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • Northern Utah Associates

    Ogden, Utah, 84403

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • University of California Irvine Comprhensive Center

    Orange, California, 92868

  • Kansas City Cancer Center, Southwest

    Overland Park, Kansas, 66210

  • Allegheny General Hospital/Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212

  • Kaiser Permanente, Northwest Region

    Portland, Oregon, 97227

  • Loma Linda Oncology Medical Group, Inc.

    Redlands, California, 92374

  • HOPE Oncology

    Richardson, Texas, 75080

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Rochester General Hospital - Lipson Cancer Center

    Rochester, New York, 14621

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Peninsula Regional Oncology and Hematology

    Salisbury, Maryland, 21801

  • California Pacific Medical Research Institute

    San Francisco, California, 94115

  • Redwood Regional Cancer Center

    Santa Rosa, California, 95403

  • Louisiana State University Health Sciences Center - Feist-Weiller Cancer Center

    Shreveport, Louisiana, 71103

  • Siouxland Hematology-Oncology Assoc., LLC

    Sioux City, Iowa, 51101

  • Hematology/Oncology of North Shore

    Skokie, Illinois, 60076

  • St. Louis University Cancer Center

    St Louis, Missouri, 63110

  • Center for Cancer Care and Research (US Oncology)

    St Louis, Missouri, 63141

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • St. Louis Cancer and Breast Institute

    St Louis, Missouri, 63141

  • Syracuse VA Medical Center

    Syracuse, New York, 13210

  • Eastchester Center for Cancer Care

    The Bronx, New York, 10469

  • Arizona Oncology Associates

    Tucson, Arizona, 85704

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724-5024

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • UT Health Center

    Tyler, Texas, 75709

  • Northwest Cancer Specialists

    Vancouver, Washington, 98684

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Deke Slayton Cancer Center

    Webster, Texas, 77598

  • Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Loyola Cancer Care & Research Ctr. at Central Dupage Hospital

    Winfield, Illinois, 60190

  • Osteopathic Medical Oncology and Hematology PC

    Woodhaven, Michigan, 28183

  • Fallon Clinic

    Worcester, Massachusetts, 01605

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  • Novartis Investigative Site

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France12 sites

  • Novartis Investigative Site

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    Marseille

  • Novartis Investigative Site

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    Paris

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Canada10 sites

  • Novartis Investigative Site

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Italy8 sites

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United Kingdom6 sites

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Poland4 sites

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Belgium3 sites

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About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Locally Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to determine if adding ASA404 to standard chemotherapy makes the cancer treatment more effective in patients with advanced lung cancer.

Being tested
ASA404, Placebo, carboplatin, Paclitaxel
Keywords
Tumor vascular disrupting agent, VDA, ASA404, non-small cell lung cancer, NSCLC
Medical subject headings
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 NCT00662597
Study groupRoleWhat they receive
ASA404ExperimentalNot described
Receives: Drug: ASA404; Drug: carboplatin; Drug: Paclitaxel
ASA40 PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: carboplatin; Drug: Paclitaxel

What is being measured

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

  1. Overall survival rate

    Measured: Patients will be followed every six weeks for survival following treatment completion, discontinuation, or documented disease progression until either death or the data cut off date.

Secondary outcomes (1)

  1. Overall survival of patients with squamous and non-squamous NSCLC

    Measured: Patients will be followed every six weeks for survival following treatment completion, discontinuation, or documented disease progression until either death or the data cut off date.

Timeline

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

  1. First posted21 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionMay 2010
  4. Study completionMay 2010

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00662597
Sponsor's protocol ID
CASA404A2301
Acronym
ATRACT-1
Status last verified
May 2012
First submitted
17 Apr 2008
Last updated
24 Dec 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ASA404, carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 248 sites in 26 countries.

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 18 inclusion and 30 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: stopped early, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 248 sites in United States, Japan, Germany, France, Canada and 21 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early. Results are not available in the source record.

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?

Overall survival rate (time frame: Patients will be followed every six weeks for survival following treatment completion, discontinuation, or documented disease progression until either death or the data cut off date.). 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 NCT00662597.

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 Dec 2020.

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