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Crizotinib in Treating Patients with Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT02201992
Protocol IDs
E4512 (primary)
NCI-2014-01507
U10CA180820
U10CA021115
Study Sponsor
ECOG-ACRIN Cancer Research Group
NCI Full Details
http://clinicaltrials.gov/show/NCT02201992

Summary

This phase III ALCHEMIST trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate whether adjuvant therapy with crizotinib will result in improved disease-free survival (DFS) for patients with stage IB >= 4cm, II and IIIA, ALK-positive non-small cell lung cancer (NSCLC) following surgical resection.

SECONDARY OBJECTIVES:
I. To evaluate and compare overall survival (OS) associated with crizotinib.
II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
III. To collect tumor tissue and blood specimens for future research.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo observation.

Patients in both arms also undergo computed tomography (CT) throughout the trial. Patients may undergo blood and tissue sample collection on the trial.

After completion of study treatment, patients are followed up every 6 months if < 4 or 5 years from study entry, and every 12 months if 5-10 or 6-10 years from study entry.

Treatment Sites


Atlanta Cancer Care - Alpharetta
3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005
Kristin Sieverding
770-777-1315
www.atlantacancercare.com

Doctors:

Colleen S. Austin MD
Silpa C. Reddy MD
Sreekanth C. Reddy MD
Ronald G. Steis MD

Atlanta Cancer Care - Conyers
1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Doctors:

Richard A. Carter MD

Atlanta Cancer Care - Cumming
1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
Renee Gaiter
770-205-5292 x1041
www.atlantacancercare.com

Doctors:

Sreekanth C. Reddy MD
Ronald G. Steis MD
Amelia B. Zelnak MD
Kelly A. May MD

Atlanta Cancer Care - Decatur
2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Doctors:

Lijo Simpson MD

Atlanta Cancer Care - Stockbridge
7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
Andrena Jefferson
678 466-2069
www.atlantacancercare.com

Doctors:

Gurinderjit K. Sidhu MD
Lijo Simpson MD

Atlanta Cancer Care - Tower
5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342
404-303-3355
www.atlantacancercare.com

Doctors:

Colleen S. Austin MD
Silpa C. Reddy MD
Sreekanth C. Reddy MD
Kelly A. May MD

Atrium Health Navicent
Oncology Research, Atrium Health Navicent
777 Hemlock Street, MSC 123
(PACC 800 1st St, Ste 250)
Macon, GA 31201
Oncology Research Nurse
4786332152
www.Atriumhealth.org

Study Coordinator:
Oncology Research Nurse
(478) 633-2152

Doctors:

Linda K. Hendricks MD
Bradley T. Sumrall MD
Harry F. Moore, Jr. MD

Georgia Cancer Specialists - Athens
125 King Avenue
Suite 200
Athens, GA 30606
Cynthia Pirkle
www.gacancer.com

Doctors:

Ranjana S. Bhargava MD
Priya Rudolph

Georgia Cancer Specialists - Canton
228 Riverstone Drive
Canton, GA 30114
www.gacancer.com

Doctors:

Louis Crain Garrot MD
Gena H. Volas-Redd MD
Lynn M. Zemsky MD

Georgia Cancer Specialists - CenterPointe
1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
Anila Lokhandwala
404-256-4777 ext 9242
www.gacancer.com

Doctors:

Rodolfo E. Bordoni MD
Pradeep C. Jolly MD

Georgia Cancer Specialists - Kennestone
790 Church Street
Suite 335
Marietta, GA 30060
Greta Dudley
www.gacancer.com

Doctors:

Louis Crain Garrot MD
Gena H. Volas-Redd MD
Lynn M. Zemsky MD

Georgia Cancer Specialists - Macon-Coliseum
308 Coliseum Drive
Suite 120
Macon, GA 31217
Sonia Hernandez
478-745-6130 x8152
www.gacancer.com

Doctors:

Cheryl F. Jones MD
Premila Malhotra MD

Georgia Cancer Specialists - Stemmer
2712 Lawrenceville Highway
Decatur, GA 30033
Nina Patel
770-496-5555
www.gacancer.com

Doctors:

Jayanthi Srinivasiah MD
Simbo O. Aduloju MD
Aaron R. Alizadeh MD
Kathleen E. Lambert MD

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
Alaina Underberg
912-819-5778
www.sjchs.org

Doctors:

Mark A. Taylor MD
Grant C. Lewis MD
Ronald Goldberg MD
Alison Spellman MD
Gary W. Thomas MD
Majd Chahin MD

Northeast Georgia Medical Center - Gainesville
NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
Trena Davis
770-219-8822
www.nghs.com

Study Coordinator:
Trena Davis BSN, RN, CRCC
770-219-8822

Doctors:

Andre M. Kallab MD
Richard J. LoCicero MD
Padma C. Nadella MD
Charles H. Nash, III MD, FACP
Saloni H. Tanna MD
Christina A. Saurel MD

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
Northside Hospital Central Research Department
404-303-3355
www.northside.com

Study Coordinator:
404-303-3355

Doctors:

Pradeep C. Jolly MD
Cheryl F. Jones MD
Jayanthi Srinivasiah MD
Gena H. Volas-Redd MD
Amelia B. Zelnak MD
Simbo O. Aduloju MD
Premila Malhotra MD
Aaron R. Alizadeh MD
Kelly A. May MD
Ranjana S. Bhargava MD
Priya Rudolph
Kathleen E. Lambert MD

Piedmont Columbus Regional
1831 5th Ave
Columbus, GA 31901
www.columbusregional.com

Study Coordinator:
Jay Pitts, BS, CPhT
706-596-5426

Doctors:

Wilbur B. Bassett, Jr. MD
Andrew W. Pippas MD
Peter Q. Jiang MD
Suresh Nukala MD
 
For a complete listing of all trial sites in Georgia, please visit GeorgiaCancerInfo.org
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