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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)


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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)


Inclusion Criteria:



1. 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.)

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:

1. 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.).

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.

4. 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.

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

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival rate

Outcome 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.

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CASA404A2301

NCT ID:

NCT00662597

Start Date:

April 2008

Completion Date:

May 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Tumor vascular disrupting agent
  • VDA
  • ASA404
  • non-small cell lung cancer
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Cedars Sinai Medical CenterLos Angeles, California  90048-1804
Loyola University Medical CenterMaywood, Illinois  60153
University Hospitals of ClevelandCleveland, Ohio  44106
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Virginia Oncology AssociatesNewport News, Virginia  23606
St. Agnes Cancer CenterBaltimore, Maryland  21229
Arlington Cancer CenterArlington, Texas  76012
South Texas Cancer InstituteSan Antonio, Texas  78229
Florida Cancer SpecialistsFort Myers, Florida  33901
Medical Oncology Hematology Associates, Inc.Dayton, Ohio  45409
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Arena Oncology AssociatesGreat Neck, New York  11021
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Highlands Oncology GroupSpringdale, Arkansas  72764
Tyler Cancer CenterTyler, Texas  75702
Genesis Cancer CenterHot Springs, Arkansas  71913
Northwest Cancer SpecialistsVancouver, Washington  98664
Northern Utah AssociatesOgden, Utah  84403
Arizona Oncology AssociatesTucson, Arizona  85712-2254
Cancer Care AssociatesFresno, California  93720
California Cancer CareGreenbrae, California  94904
UC Davis Comprehensive Cancer CenterSacramento, California  95817
Virginia Cancer InstituteRichmond, Virginia  23230
Eastchester Center for Cancer CareBronx, New York  10469
Georgetown University HospitalWashington, District of Columbia  20007
Hope OncologyRichardson, Texas  75080
Texoma Cancer CenterWichita Falls, Texas  76310
The West ClinicMemphis, Tennessee  38120
Highline Medical OncologyBurien, Washington  98166
New York Oncology HematologyAlbany, New York  12208
University of Arizona Cancer CenterTucson, Arizona  85724
University of WisconsinMadison,, Wisconsin  53792-5666
Medical ConsultantsMilwaukee, Wisconsin  53215-3690
Northwest Georgia Oncology CentersMarietta, Georgia  30060
Billings ClinicBillings, Montana  59107-7000
Deke Slayton Cancer CenterWebster, Texas  77589
Syracuse VA Medical CenterSyracuse, New York  13210
University of Oklahoma Health Science CenterOklahoma City, Oklahoma  73104
Fallon ClinicWorcester, Massachusetts  01605
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Loma Linda University Cancer CenterLoma Linda, California  92354
Cancer Centers of Central Florida, PALeesburg, Florida  34788
Tennessee OncologyNashville, Tennessee  37203
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404
Sletten Cancer InstituteGreat Falls, Montana  59405
St. Louis University Cancer CenterSt. Louis, Missouri  63110
Hematology Oncology Associates of RocklandNyack, New York  10960
University of Louisville - James Graham Brown Cancer CenterLouisville, Kentucky  40202
Hematology Oncology SpecialistsMetairie, Louisiana  70006
University of South Alabama/Mitchell Cancer InstituteMobile, Alabama  36604
Alta Bates Summit Medical CenterBerkeley, California  94704
Pacific Oncology and Hematology AssociationEncinitas, California  92024
Ronald Yanagihara - Private PracticeGilroy, California  95020
University of California Irvine Comprhensive CenterOrange, California  92868
Loma Linda Oncology Medical Group, Inc.Redlands, California  92374
California Pacific Medical Research InstituteSan Francisco, California  94115
Redwood Regional Cancer CenterSanta Rosa, California  95403
Palm Beach Institute of Hematology & OncologyBoynton Beach, Florida  33435
Advanced Medical Specialties (ACORN)Miami, Florida  33176
Kootenai Cancer Center (ACORN)Couer D'Alene, Idaho  83814
Advocate Illinois Masonic Medical CenterChicago, Illinois  60657
Illinois Oncology/Warren Billhartz Cancer Ctr.Maryville, Illinois  62062
Hematology/Oncology of North ShoreSkokie, Illinois  60076
Loyola Cancer Care & Research Ctr. at Central Dupage HospitalWinfield, Illinois  60190
Ft. Wayne Oncology and HematologyFt. Wayne, Indiana  46815
Siouxland Hematology-Oncology Assoc., LLCSioux City, Iowa  51101
Kansas City Cancer Center, SouthwestOverland Park, Kansas  66210
Louisiana State University Health Sciences Center - Feist-Weiller Cancer CenterShreveport, Louisiana  71103
The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar HealthBaltimore, Maryland  21237
Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer InstituteBaltimore, Maryland  21215-5271
Peninsula Regional Oncology and HematologySalisbury, Maryland  21801
Boston VA Healthcare SystemBoston, Massachusetts  02130
Breslin Cancer CenterLansing, Michigan  48910
Osteopathic Medical Oncology and Hematology PCWoodhaven, Michigan  28183
St. Luke's Hospital - St Luke's Cancer CenterDuluth, Minnesota  55811
Kansas City Veterans Affair Medical CenterKansas City, Missouri  64128
St. Louis Cancer and Breast InstituteSt. Louis, Missouri  63141
Center for Cancer Care and Research (US Oncology)St. Louis, Missouri  63141
Rochester General Hospital - Lipson Cancer CenterRochester, New York  14621
Alamance Regional Medical Center-Cancer Ctr.Burlington, North Carolina  27215
Carolina Cancer Mgmt/Cape Fear Valley Health System/Med OncFayetteville, North Carolina  28304
Oncology Hematology Care ResearchCincinnati, Ohio  45242
Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology ProgramDayton, Ohio  45429
Cleo Craig Memorial Cancer Ctr. & Research ClinicLawton, Oklahoma  73505
Kaiser Permanente, Northwest RegionPortland, Oregon  97227
Allegheny General Hospital/Allegheny Cancer CenterPittsburg, Pennsylvania  15212
South Carolina Oncology AssociateColumbia, South Carolina  29210
Lowcountry Hematology & Oncology PAMt. Pleasant, South Carolina  29464
Texas Oncology Cancer Center of the High PlainsAmarillo, Texas  79106
Patient's Comprehensive Cancer CenterCarrolton, Texas  75010
Texas Oncology at Presbyterian HospitalDallas, Texas  75231
University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer CenterDallas, Texas  75390-9179
Texas Oncology at GarlandGarland, Texas  75042
UT Health CenterTyler, Texas  75709
Danville Hematology & OncologyDanville, Virginia  24541
Medical Oncology & Hematology Associates of Northern VirginiaFairfax, Virginia  22031
Providence Everett Medical Center/Providence regional Cancer PartnershipEverett, Washington  98201
Medical College of Wisconsin/Division of Neoplastic & Related DisordersMilwaukee, Wisconsin  53226