Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT01017601
First received: November 19, 2009
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

RATIONALE: A virus called Seneca Valley virus-001 (NTX-010) may be able to kill tumor cells without damaging normal cells. It is not yet known whether NTX-010 is more effective than a placebo in treating small cell lung cancer.

PURPOSE: This randomized phase II trial is studying NTX-010 to see how well it works compared with a placebo when given after chemotherapy in treating patients with extensive-stage small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Biological: Seneca Valley virus-001
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blinded Phase II Study of NTX-010, a Replication-Competent Picornavirus, After Standard Platinum-Containing Cytoreductive Induction Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Response rate (complete response and partial response) as assessed by RECIST criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Time-to-disease progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Quality of life as assessed by the single-item Linear Analogue Self Assessment [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 99
Study Start Date: January 2010
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Biological: Seneca Valley virus-001
Given IV
Placebo Comparator: Arm II
Patients receive a single dose of placebo IV over 1 hour on day 1.
Other: placebo
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • To compare the progression-free survival (PFS) of patients with extensive-stage small cell lung cancer treated with Seneca Valley virus-001 (NTX-010) vs placebo.

Secondary

  • To compare the overall survival (OS) of patients treated with NTX-010 vs placebo.
  • To describe the adverse events profile and safety of NTX-010 in this patient population.
  • To determine the antitumor response rate, as assessed by RECIST criteria, and duration of tumor response in this patient population.
  • To assess the quality of life of this patient population.

Exploratory

  • To determine the relationship between the presence of neutralizing antibodies and PFS.
  • To assess whether or not a slow viral clearance is associated with better response as determined by PFS.
  • To determine any potential impact of the presence of one or several neuroendocrine markers in the tumor sample (synaptophysin, chromogranin, or CD56) on PFS and OS.
  • To determine any potential relationship between presence of cell surface determinants of NTX-010 tropism in the tumor tissue and clinical outcomes such as improved PFS and OS.
  • To determine any potential relationship between the loss of integrity of IFN signaling in the tumor tissue and clinical outcomes such as improved PFS and OS.
  • To assess whether or not the presence of circulating tumor cells permissive to NTX-010 is associated with better clinical outcomes as determined by PFS and OS.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), tumor response to standard chemotherapy (partial response vs stable disease vs complete response), and time between completion of chemotherapy to randomization 1 month (≤1 month) vs 2 months (>1 month but ≤ 2 months) vs 3 months (> 2 months but ≤ 3 months). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
  • Arm II: Patients receive a single dose of placebo IV over 1 hour on day 1. In both arms, patients may also undergo prophylactic cranial irradiation (PCI) daily on days 22-35 if they have not previously undergone PCI or whole-brain radiotherapy.

Quality of life is assessed at baseline and then periodically during the study.

Blood samples are collected periodically for viral clearance and antiviral neutralizing antibody levels, circulating tumor cells, and other biomarker laboratory studies.

After completion of study therapy, patients are followed up periodically for up to 5 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of extensive-stage small cell lung cancer (SCLC)

    • No mixed histology
  • Presence of ≥ 1 neuroendocrine marker (synaptophysin, chromogranin, or CD56) in tumor tissue
  • Achieved partial response (PR), complete response (CR), or stable disease (SD) ≤ 12 weeks of completing 4-6 courses of platinum-based chemotherapy regimen for extensive-stage SCLC

    • Patients with PR or SD must have measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured as ≥ 2.0 cm but < 10 cm by chest x-ray OR as ≥ 1.0 cm but < 10 cm by CT scan, CT component of a PET/CT scan, or MRI

      • If CT scan is used, it must be used for both pre- and post-treatment tumor assessments
      • Measurable disease is not required for patients with CR
  • Brain metastases allowed provided they have been stable for ≥ 4 weeks after completion of prior radiotherapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0 or 1
  • Life expectancy of ≥ 8 weeks
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal
  • AST ≤ 3 times ULN (≤ 5 times ULN if liver has tumor involvement)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use adequate contraception
  • Able to comply with study procedures to minimize virus exposure to others
  • Willing to provide required biologic specimens
  • Willing to return to NCCTG/CTSU enrolling institution for follow-up
  • Adequate lung function (i.e., not oxygen dependent)

    • The patient is eligible if not on a 24-hour oxygen schedule
  • No second primary malignancy within the past 5 years, except for the following:

    • Carcinoma in situ of the cervix
    • Non-melanomatous skin cancer
    • History of low-grade (Gleason score ≤ 6) localized prostate cancer (even if diagnosed < 5 years prior to study entry)
    • Stage I breast cancer that was treated ≥ 5 years before study entry
    • Transitional cell carcinoma of the bladder (in situ)
  • No active hepatitis B or hepatitis C
  • No clinically significant infection
  • No significant traumatic injury within the past 4 weeks
  • No concurrent uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to skeletal metastases)
  • Other prior radiation therapy (including WBRT, PCI, or Gamma Knife) is permitted as long as the following are true:

    • Recovered from prior radiotherapy (alopecia allowed)
    • No prior consolidation radiation therapy to the chest
    • No prior radiotherapy to > 25% of bone marrow
    • For patients without brain metastases, WBRT or standard of care PCI completed ≥ 2 weeks before administration of NTX- 010/placebo
  • More than 365 days since prior immunotherapy or biologic therapy
  • More than 4 weeks since prior major surgery* (i.e., laparotomy) or open biopsy
  • More than 2 weeks since prior minor surgery*
  • No prior exposure to the Seneca Valley virus (NTX-010), as determined by negative serum antibodies
  • No concurrent combination antiretroviral therapy for HIV-positive patients NOTE: *Insertion of a vascular access device is not considered major or minor surgery.
  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: NCT01017601

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Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants - Castro Valley
Castro Valley, California, United States, 94546
Valley Medical Oncology
Fremont, California, United States, 94538
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
El Camino Hospital Cancer Center
Mountain View, California, United States, 94040
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Bay Area Breast Surgeons, Incorporated
Oakland, California, United States, 94609
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Highland General Hospital
Oakland, California, United States, 94602
Larry G Strieff MD Medical Corporation
Oakland, California, United States, 94609
Epic Care - Oakland
Oakland, California, United States, 94612
Tom K Lee, Incorporated
Oakland, California, United States, 94609
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States, 94806
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
St. Joseph Regional Medical Center
Lewiston, Idaho, United States, 83501
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States, 46514
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46845
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States, 46545-1470
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States, 46563
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States, 46391
United States, Iowa
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center - West Lakes
Clive, Iowa, United States, 50325
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maine
York Hospital's Oncology Treatment Center
York, Maine, United States, 03909
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Minnesota Oncology - Maplewood
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59102
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States, 10940-4199
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
United States, North Dakota
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
MeritCare Broadway
Fargo, North Dakota, United States, 58102
Roger Maris Cancer Center at MeritCare Hospital
Fargo, North Dakota, United States, 58122
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Community Cancer Center
Elyria, Ohio, United States, 44035
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Toledo Hospital
Toledo, Ohio, United States, 43606
Fulton County Health Center
Wauseon, Ohio, United States, 43567
United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Erlanger Cancer Center at Erlanger Hospital - Baroness
Chattanooga, Tennessee, United States, 37403
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
United States, Washington
Overlake Cancer Center at Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
Providence Centralia Hospital
Centralia, Washington, United States, 98531-9027
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
St. Francis Hospital
Federal Way, Washington, United States, 98003
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
Rockwood Clinic Cancer Treatment Center
Spokane, Washington, United States, 99204-2967
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
Allenmore Hospital
Tacoma, Washington, United States, 98405
St. Clare Hospital
Tacoma, Washington, United States, 98499
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States, 98405-3004
CCOP - Northwest
Tacoma, Washington, United States, 98405
United States, Wisconsin
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States, 54701
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States, 54221-1450
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States, 54548
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
St. Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Julian Molina, MD, PhD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT01017601     History of Changes
Other Study ID Numbers: N0923, NCCTG-N0923, CDR0000659547, NCI-2011-01991
Study First Received: November 19, 2009
Last Updated: July 26, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014