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A Phase II Study of Dasatinib (NSC #732517, IND #73969) In Patients With Chemosensitive Relapsed Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase II Study of Dasatinib (NSC #732517, IND #73969) In Patients With Chemosensitive Relapsed Small Cell Lung Cancer


OBJECTIVES:

Primary

- Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.

Secondary

- Determine the objective response rate (complete and partial response) in patients
treated with this drug.

- Determine the overall survival of patients treated with this drug.

- Determine the toxicity of this drug in these patients.

- Evaluate surrogate biologic markers (FAK, paxillin, and SRC phosphorylation) in
peripheral mononuclear cells (PBMC) and VEGF and PDGF beta in serum.

OUTLINE: Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every
21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 3 months for 1
year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed small cell lung cancer (SCLC)

- Limited or extensive stage disease

- Progressive or recurrent disease after an initial response to first-line treatment
with a platinum-based chemotherapy with or without concurrent definitive radiotherapy
to the chest

- Chemotherapy must have been completed at least 90 days prior to documentation of
relapse

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- Lesions that are not considered measurable include the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusion

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Tumor lesions situated in a previously irradiated area, unless progression
after radiotherapy is documented in these lesions

- No known brain metastases

- Previously treated brain metastases allowed provided they are neurologically
stable for ≥ 4 weeks

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Platelet count ≥ 100,000/mm^3

- WBC ≥ 1,500/mm^3

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

- AST ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 weeks after
completion of study therapy

- No significant cardiac disease, including any of the following:

- New York Heart Association class III-IV heart disease

- Myocardial infarction or ventricular tachyarrhythmia within the past 6 months

- Prolonged QTc > 480 msec (Fridericia correction)

- Major conduction abnormality (unless a cardiac pacemaker is present)

PRIOR CONCURRENT THERAPY:

- No more than 1 prior chemotherapy regimen

- No prior dasatinib or compounds of similar chemical composition or similar biologic
therapeutic activity including, but not limited to, any inhibitors of SRC, BCR-ABL,
c-KIT, EPHA2, or PDGFRβ kinases

- At least 2 weeks since prior definitive or palliative radiotherapy

- Prior radiotherapy allowed in the context of combined modality treatment with
curative intent for limited stage disease; prophylactic cranial radiotherapy; or
palliative radiotherapy initially or at relapse

- At least 2 weeks since prior surgery and recovered

- At least 1 week since prior and no concurrent agents with proarrhythmic potential

- At least 1 week since prior and no concurrent CYP3A4 inhibitors or inducers

- At least 1 week since prior and no concurrent grapefruit concentrate

- No concurrent palliative radiotherapy

- No concurrent hormones or other chemotherapeutic agents, except steroids for adrenal
failure, hormones for noncancer-related conditions (e.g., insulin for diabetes), or
intermittent dexamethasone as an antiemetic

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent chemotherapeutic or investigational agents

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6 Week Progression Free Survival

Outcome Description:

Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method. Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Antonius Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center Hematology/Oncology Wake Forest University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00467

NCT ID:

NCT00470054

Start Date:

April 2007

Completion Date:

June 2010

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
University of Chicago Cancer Research Center Chicago, Illinois  60637
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Greenville Greenville, South Carolina  29615
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
CancerCare of Maine at Eastern Maine Medical Center Bangor, Maine  04401
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Valley Care Medical Center Pleasanton, California  94588
Kaiser Permanente Medical Office -Vandever Medical Office San Diego, California  92120
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana  46815
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center Grand Island, Nebraska  68803
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls, New York  12801
Mountainview Medical Berlin, Vermont  05602
Danville Regional Medical Center Danville, Virginia  24541
Highland General Hospital Oakland, California  94602
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Randolph Hospital Asheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community Hospital Greensboro, North Carolina  27401
Annie Penn Cancer Center Reidsville, North Carolina  27320
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Kinston Medical Specialists Kinston, North Carolina  28501
McLeod Regional Medical Center Florence, South Carolina  29501
La Grange Memorial Hospital La Grange, Illinois  60525
Veterans Affairs Medical Center - Iowa City Iowa City, Iowa  52246-2208
Center for Cancer Care at OSF Saint Anthony Medical Center Rockford, Illinois  61108
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
Galesburg Clinic, PC Galesburg, Illinois  61401
East Bay Radiation Oncology Center Castro Valley, California  94546
Contra Costa Regional Medical Center Martinez, California  94553-3156
Larry G Strieff MD Medical Corporation Oakland, California  94609
Tom K Lee, Incorporated Oakland, California  94609
Bay Area Breast Surgeons, Incorporated Oakland, California  94609
Valley Medical Oncology Consultants - Pleasanton Pleasanton, California  94588
Arroyo Grande Community Hospital Arroyo Grande, California  93420
St. Anthony's Cancer Center St. Louis, Missouri  63128
St. Mary's Regional Cancer Center at St. Mary's Medical Center Huntington, West Virginia  25702
Callahan Cancer Center at Great Plains Regional Medical Center North Platte, Nebraska  69103
Valley Medical Oncology Consultants - Castro Valley Castro Valley, California  94546
Valley Medical Oncology Fremont, California  94538
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County Martinsville, Virginia  24115