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A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMCA12 for Patients With Extensive Stage Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

Thank you

Trial Information

A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMCA12 for Patients With Extensive Stage Small Cell Lung Cancer


I. To evaluate the progression-free survival of patients with extensive stage small cell
lung cancer treated with cisplatin and etoposide with or without Hedgehog antagonist
GDC-0449 or cixutumumab.


I. To evaluate the response rate in patients treated with these regimens. II. To evaluate
the overall survival of patients treated with these regimens. III. To evaluate the toxicity
of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to gender. Patients
are randomized to 1 of 3 treatment arms.

ARM I: Patients receive cisplatin IV over 1-2 hours on day 1 and etoposide phosphate IV over
1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of
disease progression or unacceptable toxicity.

ARM II: Patients receive cisplatin and etoposide phosphate as in arm I and oral Hedgehog
antagonist GDC-0449 once daily on days 1-21. Treatment repeats every 21 days for 4 courses
in the absence of disease progression or unacceptable toxicity. Patients then receive
Hedgehog antagonist GDC-0449 alone once daily in the absence of disease progression or
unacceptable toxicity.

ARM III: Patients receive cisplatin and etoposide phosphate as in arm I and cixutumumab IV
over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab
alone once weekly in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 1 year.

Inclusion Criteria:

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

- Extensive stage disease, as defined by any of the following criteria:

- Extrathoracic metastatic disease

- Malignant pleural effusion

- Bilateral or contralateral supraclavicular adenopathy

- Measurable disease based on RECIST criteria

- CNS metastases allowed provided the patient has completed a course of CNS
radiotherapy and has stable neurologic function for ≥ 28 days prior to randomization

- Prophylactic cranial irradiation allowed in those who have a response (in the
absence of progressive disease)

- ECOG performance status 0-1

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Leukocyte count ≥ 3,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST/ALT ≤ 3 times ULN (≤ 5 times ULN if elevations are due to liver metastases)

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

- Fasting serum glucose < 120 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception for ≥ 28 days before,
during, and for ≥ 12 months after completion of study treatment

- No concurrent uncontrolled illness including, but not limited to, any of the

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Uncontrolled cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study

- No poorly controlled diabetes mellitus

- History of diabetes mellitus allowed provided blood glucose is normal and the
patient is on a stable dietary or therapeutic regimen

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to Hedgehog antagonist GDC-0449, cixutumumab, or other study

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No prior chemotherapy or biologic therapy for SCLC

- No prior therapy with other agents targeting the IGFR or the Hedgehog signaling

- No prior irradiation to the only site of measurable or evaluable disease unless that
site had subsequent evidence of progression

- Prior palliative radiotherapy to other sites of disease allowed

- More than 14 days since prior radiotherapy (28 days for radiotherapy to the CNS) and

- More than 4 weeks since prior major surgery or hormonal therapy (other than
replacement therapy) and recovered

- No other concurrent investigational or anticancer agents

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Time from randomization to death or disease progression, whichever occurs first, assessed up to 3 years

Safety Issue:


Principal Investigator

Chandra Belani

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

Related Keywords:

  • Extensive Stage Small Cell Lung Cancer
  • Recurrent Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Albert Einstein College of Medicine Bronx, New York  10461
Johns Hopkins University Baltimore, Maryland  21205
Hurley Medical Center Flint, Michigan  48503
Boulder Community Hospital Boulder, Colorado  80301-9019
Porter Adventist Hospital Denver, Colorado  80210
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
Sky Ridge Medical Center Lone Tree, Colorado  80124
North Suburban Medical Center Thornton, Colorado  80229
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Fairview Ridges Hospital Burnsville, Minnesota  55337
Hutchinson Area Health Care Hutchinson, Minnesota  55350
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Avera Cancer Institute Sioux Falls, South Dakota  57105
Marshfield Clinic Marshfield, Wisconsin  54449
Stanford University Stanford, California  94305
Methodist Medical Center of Illinois Peoria, Illinois  61636
Lehigh Valley Hospital Allentown, Pennsylvania  18103
York Hospital York, Pennsylvania  17315
Waukesha Memorial Hospital Waukesha, Wisconsin  53188
Rush University Medical Center Chicago, Illinois  60612-3824
Via Christi Regional Medical Center Wichita, Kansas  67214
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Montefiore Medical Center Bronx, New York  10467-2490
Lewistown Hospital Lewistown, Pennsylvania  17044
Mount Nittany Medical Center State College, Pennsylvania  16803
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Adena Regional Medical Center Chillicothe, Ohio  54601
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Avera McKennan Hospital and University Health Center Sioux Falls, South Dakota  57105
Medical X-Ray Center Sioux Falls, South Dakota  57105
Memorial Hospital Carthage, Illinois  62321
Hematology and Oncology Associates Chicago, Illinois  60611
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Proctor Hospital Peoria, Illinois  61614
Perry Memorial Hospital Princeton, Illinois  61356
Community Cancer Center of Monroe Monroe, Michigan  48162
Creighton University Medical Center Omaha, Nebraska  68131-2197
MeritCare Medical Group Fargo, North Dakota  58122
Wood County Oncology Center Bowling Green, Ohio  43402
Lima Memorial Hospital Lima, Ohio  45804
Northwest Ohio Oncology Center Maumee, Ohio  43537
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Fulton County Health Center Wauseon, Ohio  43567
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Eureka Hospital Eureka, Illinois  61530
Mercy Hospital Coon Rapids, Minnesota  55433
Graham Hospital Association Canton, Illinois  61520
Holy Family Medical Center Des Plaines, Illinois  60016
Hematology Oncology Associates of Illinois-Highland Park Highland Park, Illinois  60035
Trinity Medical Center Moline, Illinois  61265-1291
Pekin Hospital Pekin, Illinois  61554
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Ottumwa Regional Health Center Ottumwa, Iowa  52501
Bixby Medical Center Adrian, Michigan  49221
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Fairview-Southdale Hospital Edina, Minnesota  55435
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Regions Hospital Saint Paul, Minnesota  55101
Saint Francis Regional Medical Center Shakopee, Minnesota  55379
Rice Memorial Hospital Willmar, Minnesota  56201
Saint Luke's Hospital Maumee, Ohio  43537
Lancaster General Hospital Lancaster, Pennsylvania  17604-3555
Geisinger Medical Group State College, Pennsylvania  16801
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Mary Rutan Hospital Bellefontaine, Ohio  43311
Knox Community Hospital Mount Vernon, Ohio  43050
Fisher-Titus Medical Center Norwalk, Ohio  44857
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Longmont United Hospital Longmont, Colorado  80501
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Mayo Clinic in Florida Jacksonville, Florida  32224
Memorial Medical Center Springfield, Illinois  62781
University of Virginia Charlottesville, Virginia  22908
Vanderbilt University Nashville, Tennessee  37232-6305
Northwestern University Chicago, Illinois  60611
Elmhurst Memorial Hospital Elmhurst, Illinois  60126
Hennepin County Medical Center Minneapolis, Minnesota  
Case Western Reserve University Cleveland, Ohio  44106
Emory University Atlanta, Georgia  30322
Albert Einstein Medical Center Philadelphia, Pennsylvania  19141
Toledo Clinic Oregon, Ohio  43616
Riverside Methodist Hospital Columbus, Ohio  43214
Licking Memorial Hospital Newark, Ohio  43055-2899
Columbus CCOP Columbus, Ohio  43206
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado  80218
Wichita CCOP Wichita, Kansas  67214-3882
Alegent Health Immanuel Medical Center Omaha, Nebraska  68122
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska  68124
Flower Hospital Sylvania, Ohio  43560-2197
Metro-Minnesota CCOP St. Louis Park, Minnesota  
Lakeview Hospital Stillwater, Minnesota  55082
Thomas Jefferson University Hospital Philadelphia, Pennsylvania  19131
Decatur Memorial Hospital Decatur, Illinois  62526
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania  17033
Butler Memorial Hospital Butler, Pennsylvania  16001
The Medical Center of Aurora Aurora, Colorado  80012
Penrose-Saint Francis Healthcare Colorado Springs, Colorado  80907
Saint Anthony Central Hospital Denver, Colorado  80204
Exempla Saint Joseph Hospital Denver, Colorado  80218
Colorado Cancer Research Program CCOP Denver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado  81502
Saint Mary Corwin Medical Center Pueblo, Colorado  81004
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
The Hospital of Central Connecticut New Britain, Connecticut  06050
Veterans Administration Medical Center Decatur, Georgia  30033
Saint Joseph's-Candler Health System Savannah, Georgia  31405
John H Stroger Jr Hospital of Cook County Chicago, Illinois  60612-3785
Evanston CCOP-NorthShore University HealthSystem Evanston, Illinois  60201
Provena Saint Mary's Hospital Kankakee, Illinois  60901
North Shore Hematology Oncology Libertyville, Illinois  60048
Stoffel, Thomas J MD (UIA Investigator) Moline, Illinois  61265
Garneau, Stewart C MD (UIA Investigator) Moline, Illinois  61265
Sharis, Christine M MD (UIA Investigator) Moline, Illinois  61265
Porubcin, Michael MD (UIA Investigator) Moline, Illinois  61265
Community Cancer Center Foundation Normal, Illinois  61761
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois  61350
Ottawa Regional Hospital and Healthcare Center Ottawa, Illinois  61350
Pekin Cancer Treatment Center Pekin, Illinois  61554
Illinois Oncology Research Association CCOP Peoria, Illinois  61615
Illinois CancerCare-Peoria Peoria, Illinois  61615
Illinois Valley Hospital Peru, Illinois  61354
Hematology Oncology Associates of Illinois - Skokie Skokie, Illinois  60076
Saint Margaret's Hospital Spring Valley, Illinois  61362
McFarland Clinic Ames, Iowa  50010
Constantinou, Costas L MD (UIA Investigator) Bettendorf, Iowa  52722
Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa  50325
Iowa Oncology Research Association CCOP Des Moines, Iowa  50309
Mercy Capitol Des Moines, Iowa  50307
Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa  50309
Mercy Medical Center - North Iowa Mason City, Iowa  50401
Mercy Medical Center-Sioux City Sioux City, Iowa  51104
Saint Luke's Regional Medical Center Sioux City, Iowa  51104
Siouxland Hematology - Oncology Associates Sioux City, Iowa  51101
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Hickman Cancer Center Adrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital Monroe, Michigan  48162
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Merit Care Clinic Bemidji Bemidji, Minnesota  56601
Saint Mary's Medical Center Duluth, Minnesota  55805
Miller-Dwan Hospital Duluth, Minnesota  55805
Unity Hospital Fridley, Minnesota  55432
Saint John's Hospital - Healtheast Maplewood, Minnesota  55109
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota  55109
North Memorial Medical Health Center Robbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-Woodbury Woodbury, Minnesota  55125
Lincoln Medical Education Foundation Cancer Resource Center Lincoln, Nebraska  68510
Missouri Valley Cancer Consortium CCOP Omaha, Nebraska  68106
Nevada Cancer Research Foundation CCOP Las Vegas, Nevada  89106
Hunterdon Medical Center Flemington, New Jersey  08822
Sparta Cancer Treatment Center Sparta, New Jersey  07871
New York University Langone Medical Center New York, New York  10016
Dickstein Cancer Treatment Center White Plains, New York  10601
Meritcare Hospital Fargo, North Dakota  58122
Aultman Health Foundation Canton, Ohio  44710
Doctors Hospital Columbus, Ohio  43228
Grant Medical Center Columbus, Ohio  43215
Mount Carmel Health Center West Columbus, Ohio  43222
Hematology Oncology Center Incorporated Elyria, Ohio  44035
Marietta Memorial Hospital Marietta, Ohio  45750
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee, Ohio  43537
Saint Charles Hospital Oregon, Ohio  43616
North Coast Cancer Care Sandusky, Ohio  44870
Toledo Community Hospital Oncology Program CCOP Toledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy Hospital Toledo, Ohio  43623
University of Toledo Toledo, Ohio  43614
The Toledo Hospital Toledo, Ohio  43606
Saint Vincent Mercy Medical Center Toledo, Ohio  43608
Saint Ann's Hospital Westerville, Ohio  43081
Genesis HealthCare System Zanesville, Ohio  43701
Ephrata Cancer Center Ephrata, Pennsylvania  17522
Hematology and Oncology Associates of North East Pennsylvania Scranton, Pennsylvania  18508
Scranton Hematology Oncology Scranton, Pennsylvania  18510
Mercy Hospital Scranton, Pennsylvania  18501
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
Sanford Cancer Center-Oncology Clinic Sioux Falls, South Dakota  57104
Sanford University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
Fredericksburg Oncology Inc Fredericksburg, Virginia  22401
Wheeling Hospital Wheeling, West Virginia  26003
Dean Hematology and Oncology Clinic Madison, Wisconsin  53717
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin  54548
Oconomowoc Memorial Hospital-ProHealth Care Inc Oconomowoc, Wisconsin  53066-3896
Marshfield Clinic at James Beck Cancer Center Rhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake Center Rice Lake, Wisconsin  54868
Stony Brook University Medical Center Stony Brook, New York  11794
Illinois CancerCare-Bloomington Bloomington%, Illinois  61701
Illinois CancerCare-Canton Canton, Illinois  61520
Illinois CancerCare-Carthage Carthage, Illinois  62321
Illinois CancerCare-Eureka Eureka, Illinois  61530
Illinois CancerCare-Havana Havana, Illinois  62644
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare-Macomb Macomb, Illinois  61455
Illinois CancerCare-Monmouth Monmouth, Illinois  61462
Illinois CancerCare-Community Cancer Center Normal, Illinois  61761
Illinois CancerCare-Pekin Pekin, Illinois  61603
Illinois CancerCare-Peru Peru, Illinois  61354
Illinois CancerCare-Princeton Princeton, Illinois  61356
Illinois CancerCare-Spring Valley Spring Valley, Illinois  61362
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
Hackensack University Medical CCOP Hackensack, New Jersey  07601
North Coast Cancer Care-Clyde Clyde, Ohio  43410
Community Health Partners Regional Medical Center Elyria, Ohio  44035
Saint Mary Medical and Regional Cancer Center Langhorne, Pennsylvania  19047
Vanderbilt-Ingram Cancer Center Cool Springs Franklin, Tennessee  37067
West Virginia University Charleston Charleston, West Virginia  25304
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin  54729
Medical Consultants Limited Milwaukee, Wisconsin  53215
Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Adams Cancer Center Gettysburg, Pennsylvania  17325
Cherry Tree Cancer Center Hanover, Pennsylvania  17331
Spector, David MD (UIA Investigator) Moline, Illinois  61265
Doctors Carrol, Sheth, Raghavan Louisville, Kentucky  40215
Gundersen Lutheran La Crosse, Wisconsin  54601
New York Oncology Hematology PC -Albany Medical Center Albany, New York  12208
New York Oncology Hematology PC - Albany Albany, New York  12206
New York Oncology Hematology PC - Amsterdam Amsterdam, New York  12010
New York Oncology Hematology PC-Hudson Hudson, New York  12534
New York Oncology Hematology PC - Latham Latham, New York  12110
New York Oncology Hematology PC - Rexford Rexford, New York  12148
New York Oncology Hematology PC - Troy Troy, New York  12180
Boca Raton Regional Hospital Boca Raton, Florida  33486
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Essentia Health Duluth Clinic CCOP Duluth, Minnesota  55805
Toledo Clinic Cancer Centers-Oregon Oregon, Ohio  43616
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Illinois Cancer Specialists-Niles Niles, Illinois  60714
Springfield Regional Medical Center Springfield, Ohio  45505
Lake Region Healthcare Corporation-Cancer Care Fergus Falls, Minnesota  56537
Guthrie Clinic-Robert Packer Hospital Sayre, Pennsylvania  18840
Blue Ridge Medical Specialists PC Bristol, Tennessee  37620