ASA404 or Placebo in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Stage IIIb/IV Non-Small Cell Lung Cancer
NCT ID: NCT00662597
Last Updated: 2020-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1285 participants
INTERVENTIONAL
2008-04-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ASA404
ASA404
carboplatin
Paclitaxel
ASA40 Placebo
Placebo
carboplatin
Paclitaxel
Interventions
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ASA404
Placebo
carboplatin
Paclitaxel
Eligibility Criteria
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Inclusion Criteria
2. Newly diagnosed Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease
3. 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.)
4. Age ≥ 18 years old
5. WHO Performance Status of 0-1
6. Measurable or non-measurable disease per RECIST criteria (Post-text supplement 1)
7. 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).
8. Life expectancy ≥ 12 weeks
9. Written informed consent obtained according to local guidelines
Exclusion Criteria
2. Patients with a history of another primary malignancy ≤ 5 years, with the exception of non-melanoma skin cancer or cervical cancer in situ.
3. Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
5. Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to randomization
6. Prior exposure to Tumor-VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF receptor agents, anti-EGFR agents \[bevacizumab, cetuximab, etc.\])
7. Pleural effusion that causes ≥ CTC grade 2 dyspnea
8. Patients with systolic BP \> 160 mm Hg and/or diastolic BP \>90 mm Hg
9. Patients with recent hemoptysis associated with NSCLC (\> 1 teaspoon in a single episode within 4 weeks)
10. 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
11. Concomitant use of drugs with a risk of causing Torsades de Pointes (See Table 6-3)
12. 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.
13. Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
14. 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)
15. 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/)
16. 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).
17. Significant neurologic or psychiatric disorder which could compromise participation in the study Patient unwilling or unable to comply with the protocol
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of South Alabama/Mitchell Cancer Institute
Mobile, Alabama, United States
Arizona Oncology Associates
Tucson, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Highlands Oncology Group
Bentonville, Arkansas, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
Alta Bates Summit Medical Center
Berkeley, California, United States
Pacific Oncology and Hematology Association
Encinitas, California, United States
Cancer Care Associates
Fresno, California, United States
Ronald Yanagihara - Private Practice
Gilroy, California, United States
California Cancer Care
Greenbrae, California, United States
Moores UCSD Cancer Center
La Jolla, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California Irvine Comprhensive Center
Orange, California, United States
Loma Linda Oncology Medical Group, Inc.
Redlands, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
California Pacific Medical Research Institute
San Francisco, California, United States
Redwood Regional Cancer Center
Santa Rosa, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Palm Beach Institute of Hematology & Oncology
Boynton Beach, Florida, United States
Florida Cancer Specialists
Bradenton, Florida, United States
Cancer Centers of Central Florida, PA
Leesburg, Florida, United States
Advanced Medical Specialties (ACORN)
Miami, Florida, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Kootenai Cancer Center (ACORN)
Coeur d'Alene, Idaho, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Illinois Oncology/Warren Billhartz Cancer Ctr.
Maryville, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Hematology/Oncology of North Shore
Skokie, Illinois, United States
Loyola Cancer Care & Research Ctr. at Central Dupage Hospital
Winfield, Illinois, United States
Ft. Wayne Oncology and Hematology
Fort Wayne, Indiana, United States
Siouxland Hematology-Oncology Assoc., LLC
Sioux City, Iowa, United States
Kansas City Cancer Center, Southwest
Overland Park, Kansas, United States
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States
Hematology Oncology Specialists
Metairie, Louisiana, United States
Louisiana State University Health Sciences Center - Feist-Weiller Cancer Center
Shreveport, Louisiana, United States
St. Agnes Cancer Center
Baltimore, Maryland, United States
Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer Institute
Baltimore, Maryland, United States
The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar Health
Baltimore, Maryland, United States
Peninsula Regional Oncology and Hematology
Salisbury, Maryland, United States
Boston VA Healthcare System
Boston, Massachusetts, United States
Fallon Clinic
Worcester, Massachusetts, United States
Breslin Cancer Center
Lansing, Michigan, United States
Osteopathic Medical Oncology and Hematology PC
Woodhaven, Michigan, United States
St. Luke's Hospital - St Luke's Cancer Center
Duluth, Minnesota, United States
Kansas City Veterans Affair Medical Center
Kansas City, Missouri, United States
St. Louis University Cancer Center
St Louis, Missouri, United States
Center for Cancer Care and Research (US Oncology)
St Louis, Missouri, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
St. Louis Cancer and Breast Institute
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
Sletten Cancer Institute
Great Falls, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Arena Oncology Associates
Lake Success, New York, United States
New York Oncology Hematology
Latham, New York, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
Rochester General Hospital - Lipson Cancer Center
Rochester, New York, United States
Syracuse VA Medical Center
Syracuse, New York, United States
Eastchester Center for Cancer Care
The Bronx, New York, United States
Alamance Regional Medical Center-Cancer Ctr.
Burlington, North Carolina, United States
Carolina Cancer Mgmt/Cape Fear Valley Health System/Med Onc
Fayetteville, North Carolina, United States
Akron City Hospital
Akron, Ohio, United States
Oncology Hematology Care Research
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology Program
Dayton, Ohio, United States
Medical Oncology Hematology Associates, Inc.
Dayton, Ohio, United States
Cleo Craig Memorial Cancer Ctr. & Research Clinic
Lawton, Oklahoma, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Kaiser Permanente, Northwest Region
Portland, Oregon, United States
Allegheny General Hospital/Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
South Carolina Oncology Associate
Columbia, South Carolina, United States
Lowcountry Hematology & Oncology PA
Mt. Pleasant, South Carolina, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology Cancer Center of the High Plains
Amarillo, Texas, United States
Arlington Cancer Center
Arlington, Texas, United States
Patient's Comprehensive Cancer Center
Carrollton, Texas, United States
South Texas Cancer Institute
Corpus Christi, Texas, United States
Cancer Care Centers of South Texas
Dallas, Texas, United States
Texas Oncology at Presbyterian Hospital
Dallas, Texas, United States
University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer Center
Dallas, Texas, United States
Texas Oncology at Garland
Garland, Texas, United States
HOPE Oncology
Richardson, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
UT Health Center
Tyler, Texas, United States
Deke Slayton Cancer Center
Webster, Texas, United States
Texoma Cancer Center
Wichita Falls, Texas, United States
Northern Utah Associates
Ogden, Utah, United States
Danville Hematology & Oncology
Danville, Virginia, United States
Medical Oncology & Hematology Associates of Northern Virginia
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Highline Medical Oncology
Burien, Washington, United States
Providence Everett Medical Center/Providence regional Cancer Partnership
Everett, Washington, United States
Northwest Cancer Specialists
Vancouver, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical Consultants
Milwaukee, Wisconsin, United States
Medical College of Wisconsin/Division of Neoplastic & Related Disorders
Milwaukee, Wisconsin, United States
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Buenos Aires, , Argentina
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Capital Federal, , Argentina
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Mendoza, , Argentina
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Kobe, , Japan
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Kōtō City, , Japan
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Kumamoto, , Japan
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Kurashiki, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Ōsaka-sayama, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Ube, , Japan
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Yokohama, , Japan
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's-Hertogenbosch, , Netherlands
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Eindhoven, , Netherlands
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Harderwijk, , Netherlands
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Zwolle, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Hamilton, , New Zealand
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Wellington, , New Zealand
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Lodz, , Poland
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Lublin, , Poland
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Otwock, , Poland
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Poznan, , Poland
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Singapore, , Singapore
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Seoul, , South Korea
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Seungnam, , South Korea
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Suwon, , South Korea
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Barakaldo, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Granada, , Spain
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Jaén, , Spain
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Madrid, , Spain
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Pontevedra, , Spain
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Seville, , Spain
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Zaragoza, , Spain
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Umeå, , Sweden
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Kaoshiung, , Taiwan
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Lin-Ko, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Altunizade, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Aberdeen, , United Kingdom
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Cambridge, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Sutton, , United Kingdom
Countries
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Related Links
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Results for CASA404A2301 from the Novartis Clinical Trials website
Other Identifiers
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CASA404A2301
Identifier Type: -
Identifier Source: org_study_id