Lung Cancer Clinical Trial
ASA404 or Placebo in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Stage IIIb/IV Non-Small Cell Lung Cancer
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.
Eligibility Criteria
Inclusion Criteria:
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)
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
Exclusion Criteria:
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.])
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 97 Locations for this study
Mobile Alabama, 36604, United States
Tucson Arizona, 85704, United States
Tucson Arizona, 85724, United States
Bentonville Arkansas, 72712, United States
Hot Springs Arkansas, 71913, United States
Berkeley California, 94704, United States
Encinitas California, 92024, United States
Fresno California, 93720, United States
Gilroy California, 95020, United States
Greenbrae California, 94904, United States
La Jolla California, 92093, United States
Loma Linda California, 92354, United States
Los Angeles California, 90048, United States
Orange California, 92868, United States
Redlands California, 92374, United States
Sacramento California, 95817, United States
San Francisco California, 94115, United States
Santa Rosa California, 95403, United States
Washington District of Columbia, 20007, United States
Boynton Beach Florida, 33435, United States
Bradenton Florida, 34209, United States
Leesburg Florida, 34788, United States
Miami Florida, 33176, United States
Marietta Georgia, 30060, United States
Honolulu Hawaii, 96813, United States
Coeur d'Alene Idaho, 83814, United States
Chicago Illinois, 60657, United States
Maryville Illinois, 62062, United States
Maywood Illinois, 60153, United States
Skokie Illinois, 60076, United States
Winfield Illinois, 60190, United States
Fort Wayne Indiana, 46815, United States
Sioux City Iowa, 51101, United States
Overland Park Kansas, 66210, United States
Louisville Kentucky, 40202, United States
Metairie Louisiana, 70006, United States
Shreveport Louisiana, 71103, United States
Baltimore Maryland, 21129, United States
Baltimore Maryland, 21215, United States
Baltimore Maryland, 21237, United States
Salisbury Maryland, 21801, United States
Boston Massachusetts, 02130, United States
Worcester Massachusetts, 01605, United States
Lansing Michigan, 48910, United States
Woodhaven Michigan, 28183, United States
Duluth Minnesota, 55811, United States
Kansas City Missouri, 64128, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Saint Louis Missouri, 63141, United States
Saint Louis Missouri, 63141, United States
Billings Montana, 59107, United States
Great Falls Montana, 59405, United States
Omaha Nebraska, 68198, United States
Bronx New York, 10469, United States
Lake Success New York, 11042, United States
Latham New York, 12210, United States
Nyack New York, 10960, United States
Rochester New York, 14621, United States
Syracuse New York, 13210, United States
Burlington North Carolina, 27215, United States
Fayetteville North Carolina, 28304, United States
Akron Ohio, 44309, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44106, United States
Dayton Ohio, 45429, United States
Dayton Ohio, 45429, United States
Lawton Oklahoma, 73505, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97227, United States
Pittsburgh Pennsylvania, 15212, United States
Columbia South Carolina, 29210, United States
Mount Pleasant South Carolina, 29464, United States
Chattanooga Tennessee, 37804, United States
Memphis Tennessee, 38120, United States
Nashville Tennessee, 37203, United States
Amarillo Texas, 79106, United States
Arlington Texas, 76012, United States
Carrollton Texas, 75010, United States
Corpus Christi Texas, 78405, United States
Dallas Texas, 75204, United States
Dallas Texas, 75231, United States
Dallas Texas, 75390, United States
Garland Texas, 75042, United States
Richardson Texas, 75080, United States
Tyler Texas, 75702, United States
Tyler Texas, 75709, United States
Webster Texas, 77598, United States
Wichita Falls Texas, 76310, United States
Ogden Utah, 84403, United States
Danville Virginia, 24541, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23230, United States
Burien Washington, 98166, United States
Everett Washington, 98201, United States
Vancouver Washington, 98684, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Buenos Aires , , Argentina
Capital Federal , , Argentina
Cordoba , , Argentina
La Plata , , Argentina
Mendoza , , Argentina
Rosario , , Argentina
Heidelberg , , Australia
Herston , , Australia
South Brisbane , , Australia
Duffel , , Belgium
Jette , , Belgium
Liege , , Belgium
Barretos , , Brazil
Belo Horizonte , , Brazil
Goiania , , Brazil
Jaù , , Brazil
Jaú , , Brazil
Porto Alegre , , Brazil
Santo Andre , , Brazil
Sao Paulo , , Brazil
São Paulo , , Brazil
Calgary , , Canada
Greenfield Park , , Canada
Kitchener , , Canada
London , , Canada
Moncton , , Canada
Montreal , , Canada
Rimouski , , Canada
Sainte-Foy , , Canada
Sherbrooke , , Canada
Sult Ste-Marie , , Canada
Bejing , , China
Guangzhou , , China
Shanghai , , China
Wuhan , , China
Xi'an , , China
Brno , , Czechia
Ostrava Poruba , , Czechia
Prague , , Czechia
Bobigny , , France
Boujan-sur-Libron , , France
Clamart Cedex , , France
Le Mans , , France
Limoges , , France
Lyon Cedex , , France
Marseille , , France
Nice , , France
Paris , , France
Saint Herblain , , France
Toulon Armées , , France
Tours Cedex 9 , , France
Aschaffenburg , , Germany
Bad Berka , , Germany
Berlin , , Germany
Donaustauf , , Germany
Ebensberg , , Germany
Essen , , Germany
Freiburg , , Germany
Gerlingen , , Germany
Grosshandsdorf , , Germany
Göttingen , , Germany
Heidenheim , , Germany
Koeln , , Germany
Leipzig , , Germany
Merseburg , , Germany
Muenchen , , Germany
Nuernberg , , Germany
Athens , , Greece
Heraklion Crete , , Greece
Thessaloniki , , Greece
Hong Kong , , Hong Kong
Budapest , , Hungary
Deszk , , Hungary
Mátraháza , , Hungary
Kfar-Sava , , Israel
Rehovot , , Israel
Tel-Aviv , , Israel
Tel-Hashomer , , Israel
Zrifin , , Israel
Avellino , , Italy
Milano , , Italy
Modena , , Italy
Napoli , , Italy
Orbassano , , Italy
Parma , , Italy
Perugia , , Italy
Roma , , Italy
Akashi , , Japan
Fukuoka , , Japan
Habikino , , Japan
Hiroshima , , Japan
Kashiwa , , Japan
Kobe-city , , Japan
Koto , , Japan
Kumamoto , , Japan
Kurashiki , , Japan
Matsuyama , , Japan
Nagoya , , Japan
Niigata , , Japan
Okayama , , Japan
Osaka Sayama , , Japan
Osaka , , Japan
Sapporo , , Japan
Sendai , , Japan
Ube , , Japan
Yokohama , , Japan
Seoul , , Korea, Republic of
Seungnam , , Korea, Republic of
Suwon , , Korea, Republic of
Amsterdam , , Netherlands
Breda , , Netherlands
Eindhoven , , Netherlands
Harderwijk , , Netherlands
Hertogenbosch , , Netherlands
Zwolle , , Netherlands
Auckland , , New Zealand
Christchurch , , New Zealand
Hamilton , , New Zealand
Wellington , , New Zealand
Lodz , , Poland
Lublin , , Poland
Otwock , , Poland
Poznan , , Poland
Singapore , , Singapore
Baracaldo , , Spain
Barcelona , , Spain
Córdoba , , Spain
Granada , , Spain
Jaen , , Spain
Madrid , , Spain
Pontevedra , , Spain
Sevilla , , Spain
Zaragoza , , Spain
Umea , , Sweden
Kaoshiung , , Taiwan
Lin-Ko , , Taiwan
Taichung , , Taiwan
Tainan , , Taiwan
Taipei , , Taiwan
Altunizade , , Turkey
Ankara , , Turkey
Istanbul , , Turkey
Izmir , , Turkey
Aberdeen , , United Kingdom
Cambridge , , United Kingdom
Leicester , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
Sutton , , United Kingdom
How clear is this clinincal trial information?