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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00662597

Run by

Novartis Pharmaceuticals

People needed

1285

Starts

2008-04-01

Expected to finish

2010-05-01

Last updated by the study team

2020-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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
• University of South Alabama/Mitchell Cancer Institute — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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