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A Study of Avastin (Bevacizumab) in Combination With Standard of Care Treatment in Patients With Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01351415
First received: May 9, 2011
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This open-label, randomized, multicenter study will evaluate the efficacy and sa fety of Avastin (bevacizumab) in combination with standard of care treatment in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Patients will be enrolled at documentation of progression of disease (PD) after 4-6 cycl es of first-line treatment with Avastin plus a platinum doublet-containing thera py and a minimum of two cycles of Avastin maintenance treatment prior to PD. Pat ients will be randomly assigned to one of two treatment arms to receive either A vastin plus standard of care treatment or standard of care treatment alone.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: Standard of care treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First (1st)-Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Disease control rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: bevacizumab [Avastin]
7.5 or 15 mg/kg intravenously on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent
Drug: Standard of care treatment
Investigator's choice of standard of care treatment on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent
Active Comparator: B Drug: Standard of care treatment
Investigator's choice of standard of care treatment on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, age >/=18 years
  • Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
  • Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment 4-6 cycles of Avastin plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Avastin (monotherapy) maintenance treatment prior to first progression of disease
  • No treatment interruption of Avastin treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
  • Randomization within 4 weeks of progression of disease
  • At least one unidimensionally measurable lesion meeting RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

  • Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
  • History of hemoptysis >/=grade 2 within 3 months of randomization
  • Major cardiac disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351415

Contacts
Contact: Reference Study ID Number: MO22097 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Alabama
Completed
Mobile, Alabama, United States, 36688
United States, Arizona
Recruiting
Glendale, Arizona, United States, 85304
Recruiting
Glendale, Arizona, United States, 85306
United States, Arkansas
Recruiting
Jonesboro, Arkansas, United States, 72401
United States, California
Recruiting
Burbank, California, United States, 91505
Recruiting
Encinitas, California, United States, 92008
Recruiting
La Jolla, California, United States, 92037-1027
Recruiting
Sacramento, California, United States, 95816
Recruiting
San Luis Obispo, California, United States, 93401
Recruiting
Whittier, California, United States, 90603
United States, Connecticut
Recruiting
New Britian, Connecticut, United States, 06050
Completed
Norwich, Connecticut, United States, 06360
United States, Florida
Recruiting
Boca Raton, Florida, United States, 33428
Recruiting
Jacksonville, Florida, United States, 32207
Recruiting
Jacksonville, Florida, United States, 32256
Recruiting
Miami Beach, Florida, United States, 33140
Recruiting
Rockledge, Florida, United States, 32955
United States, Georgia
Completed
Atlanta, Georgia, United States, 30322
Suspended
Savannah, Georgia, United States, 31405
United States, Idaho
Recruiting
Post Falls, Idaho, United States, 83854
United States, Illinois
Completed
Elk Grove Village, Illinois, United States, 60007
Recruiting
Evanston, Illinois, United States, 60201
Completed
Joliet, Illinois, United States, 60435
Completed
Niles, Illinois, United States, 60714
Completed
River Forest, Illinois, United States, 60305
United States, Indiana
Recruiting
Indianapolis, Indiana, United States, 46237
Recruiting
Newburgh, Indiana, United States, 47630
United States, Iowa
Recruiting
Ames, Iowa, United States, 50010
United States, Kansas
Recruiting
Wichita, Kansas, United States, 67214-3728
United States, Kentucky
Completed
Lexington, Kentucky, United States, 40536
Recruiting
Louisville, Kentucky, United States, 40245
United States, Louisiana
Recruiting
Baton Rouge, Louisiana, United States, 70809
Completed
Lafayette, Louisiana, United States, 70508
United States, Maine
Recruiting
Scarborough, Maine, United States, 04074
Recruiting
York, Maine, United States, 03909
United States, Maryland
Completed
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Completed
Boston, Massachusetts, United States, 02111
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States, 48106
Completed
Detroit, Michigan, United States, 48202
Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Minnesota
Recruiting
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Recruiting
St Joseph, Missouri, United States, 64507
Recruiting
St. Louis, Missouri, United States, 63131
United States, New York
Recruiting
Stony Brook, New York, United States, 11794-9447
United States, North Carolina
Recruiting
Hickory, North Carolina, United States, 28602
United States, Ohio
Recruiting
Canton, Ohio, United States, 44710
Recruiting
Columbus, Ohio, United States, 43219
Completed
Dayton, Ohio, United States, 45420
Recruiting
Middletown, Ohio, United States, 45042
Recruiting
Toledo, Ohio, United States, 43617
United States, Oregon
Recruiting
Coos Bay, Oregon, United States, 97420
United States, Pennsylvania
Completed
Bethlehem, Pennsylvania, United States, 18015
Recruiting
Dunmore, Pennsylvania, United States, 18512
Completed
Langhorne, Pennsylvania, United States, 19047
Recruiting
Philadelphia, Pennsylvania, United States, 19104
Recruiting
Philadelphia, Pennsylvania, United States, 19140
Completed
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Recruiting
Pawtucket, Rhode Island, United States, 02860
United States, Tennessee
Recruiting
Knoxville, Tennessee, United States, 37920
Recruiting
Memphis, Tennessee, United States, 38120
United States, Texas
Recruiting
Dallas, Texas, United States, 75390-9015
United States, Virginia
Recruiting
Portsmouth, Virginia, United States, 23704
Recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Recruiting
Spokane, Washington, United States, 99208
United States, Wisconsin
Completed
Appleton, Wisconsin, United States, 54915
Completed
La Crosse, Wisconsin, United States, 54601
Completed
Madison, Wisconsin, United States, 53792
Argentina
Active, not recruiting
Buenos Aires, Argentina, C1426ANZ
Active, not recruiting
La Pampa, Argentina, 6300
Terminated
Mar Del Plata, Argentina, 7600
Completed
Rosario, Argentina, S2000DSV
Completed
Santa Fe, Argentina, 03000
Active, not recruiting
Viedma, Rio Negro, Argentina, 8500
Austria
Recruiting
Hohenems, Austria, 6845
Completed
Innsbruck, Austria, 6020
Completed
Natters, Austria, 6161
Recruiting
Steyr, Austria, 4400
Recruiting
Wels, Austria, 4600
Completed
Wien, Austria, 1140
Terminated
Wien, Austria, 1090
Recruiting
Wien, Austria, 1130
Belgium
Recruiting
Bruxelles, Belgium, 1180
Brazil
Recruiting
Salvador, BA, Brazil, 40170-110
Terminated
Fortaleza, CE, Brazil, 60125-120
Recruiting
Brasilia, DF, Brazil, 70390-150
Recruiting
Brasilia, DF, Brazil, 70200-730
Completed
Taguatinga, DF, Brazil, 72110-980
Recruiting
Rio De Janeiro, RJ, Brazil, 22290-160
Recruiting
Ijui, RS, Brazil, 98700-000
Terminated
Itajai, SC, Brazil, 88301-220
Terminated
Sao Paulo, SP, Brazil, 01321-001
Recruiting
Sao Paulo, SP, Brazil, 01509-010
Denmark
Recruiting
Hillerod, Denmark, 3400
France
Recruiting
Aix En Provence, France, 13617
Recruiting
Caen, France, 14076
Not yet recruiting
Chambray Les Tours, France, 37175
Recruiting
Creteil, France, 94010
Recruiting
Gleize, France, 69400
Recruiting
Lille, France, 59037
Recruiting
Lille, France, 59020
Recruiting
Lyon, France, 69394
Recruiting
Marseille, France, 13915
Completed
Marseille, France, 13285
Recruiting
Nice, France, 06189
Recruiting
Pierre Benite, France, 69310
Recruiting
Pontoise, France, 95300
Recruiting
Saint Herblain, France, 44805
Recruiting
St-Priest-En-Jarez, France, 42271
Recruiting
Strasbourg, France, 67065
Recruiting
Toulon, France, 83041
Recruiting
Toulon, France, 83056
Completed
Toulouse, France, 31076
Recruiting
Vesoul, France, 70014
Germany
Recruiting
Bad Berka, Germany, 99437
Terminated
Bergisch Gladbach, Germany, 51465
Recruiting
Esslingen, Germany, 73730
Recruiting
Frankfurt, Germany, 60488
Recruiting
Gera, Germany, 07548
Recruiting
Grosshansdorf, Germany, 22927
Recruiting
Halle (Saale), Germany, 06120
Terminated
Homburg/Saar, Germany, 66421
Terminated
Immenhausen, Germany, 34376
Recruiting
Karlsruhe, Germany, 76137
Recruiting
Leipzig, Germany, 04357
Terminated
Leipzig, Germany, 04207
Recruiting
Minden, Germany, 32429
Recruiting
Muenchen, Germany, 80336
Recruiting
Oldenburg, Germany, 26121
Greece
Recruiting
Athens, Greece, 11527
Recruiting
Neo Faliro, Greece, 18574
Terminated
Thessaloniki, Greece, 570 10
Terminated
Thessaloniki, Greece, 57001
Italy
Recruiting
Avellino, Campania, Italy, 83100
Recruiting
Napoli, Campania, Italy, 80131
Recruiting
Roma, Lazio, Italy, 00152
Recruiting
Roma, Lazio, Italy, 00128
Recruiting
Genova, Liguria, Italy, 16132
Terminated
Saronno, Lombardia, Italy, 21047
Recruiting
Pisa, Toscana, Italy, 56124
Japan
Recruiting
Aichi, Japan, 464-8681
Active, not recruiting
Chiba, Japan, 277-8577
Recruiting
Ehime, Japan, 791-0280
Active, not recruiting
Fukuoka, Japan, 811-1395
Recruiting
Hyogo, Japan, 673-8558
Recruiting
Kanagawa, Japan, 236-0051
Recruiting
Kanagawa, Japan, 240-8555
Active, not recruiting
Miyagi, Japan, 981-1293
Recruiting
Okayama, Japan, 700-8558
Active, not recruiting
Osaka, Japan, 537-8511
Recruiting
Osaka, Japan, 534-0021
Recruiting
Shizuoka, Japan, 411-8777
Active, not recruiting
Tokyo, Japan, 135-8550
Completed
Tokyo, Japan, 104-0045
Jordan
Not yet recruiting
Amman, Jordan, 13046 / 11942
Lebanon
Recruiting
Beirut, Lebanon
Recruiting
Beirut, Lebanon, 99999
Recruiting
Beirut, Lebanon, 11-236
Mexico
Recruiting
Aguascalientes, Mexico, 20230
Completed
Mexico City, Mexico, 14140
Recruiting
Mexico City, Mexico
Netherlands
Recruiting
Breda, Netherlands, 4818 CK
Active, not recruiting
Den Haag, Netherlands, 2504 LN
Recruiting
Eindhoven, Netherlands, 5623 EJ
Terminated
Harderwijk, Netherlands, 3844 DG
Active, not recruiting
Maastricht, Netherlands, 6202 AZ
Recruiting
Nieuwegein, Netherlands, 3435 CM
Oman
Terminated
Muscat, Oman, P.O Box 35
Slovakia
Completed
Banska Bystrica, Slovakia, 975 17
Completed
Bratislava, Slovakia, 826 06
Completed
Kosice, Slovakia, 04001
Recruiting
Nitra, Slovakia, 949 88
Spain
Recruiting
Barakaldo, Vizcaya, Spain, 48903
Recruiting
Alicante, Spain, 3010
Recruiting
Madrid, Spain, 28046
Recruiting
Madrid, Spain, 28040
Recruiting
Madrid, Spain, 28033
Recruiting
Valencia, Spain, 46017
Recruiting
Valencia, Spain, 46010
Recruiting
Zaragoza, Spain, 50009
United Arab Emirates
Recruiting
Al Ain, United Arab Emirates, 15258
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01351415     History of Changes
Other Study ID Numbers: MO22097
Study First Received: May 9, 2011
Last Updated: November 3, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014