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A Randomized Phase II Trial of Weekly Topotecan With and Without AVE0005 (Aflibercept; NSC-724770) in Patients With Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)


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

Thank you

Trial Information

A Randomized Phase II Trial of Weekly Topotecan With and Without AVE0005 (Aflibercept; NSC-724770) in Patients With Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)


PRIMARY OBJECTIVES:

I. Evaluate the efficacy of topotecan hydrochloride with vs without aflibercept
(ziv-aflibercept), in terms of progression-free survival at 3 months, in patients with
extensive stage small cell lung cancer previously treated with platinum-based therapy.

SECONDARY OBEJCTIVES:

I. Assess the response rate (confirmed and unconfirmed, complete and partial responses) in a
subset of patients with measurable disease.

II. Assess the overall survival of these patients. III. Evaluate the frequency and severity
of toxicities of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior
platinum-based therapy (platinum-sensitive disease vs platinum-refractory disease). Patients
are randomized to 1 of 2 treatment arms.

ARM I: Patients receive ziv-aflibercept IV over 1 hour on day 1 and topotecan hydrochloride
IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in
the absence of disease progression or unacceptable toxicity. Patients with responsive or
stable disease after 4 courses may then receive ziv-aflibercept IV on day 1 and topotecan
hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.

ARM II: Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then
receive topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for up to 2 years.


Inclusion Criteria:



- Histologically or cytologically confirmed extensive stage small cell lung cancer

- Progressive or recurrent disease following one (and only one) standard
first-line platinum-containing regimen (cisplatin or carboplatin)

- Measurable or non-measurable disease per RECIST criteria

- Disease must be outside a previously irradiated field OR a new lesion must be
inside the irradiated field

- Disease must be outside a previously resected area OR a new lesion must be
present

- No known brain metastasis unless the metastasis has been treated and is stable for ≥
3 months prior to study entry

- No leptomeningeal involvement or brain stem metastasis

- Zubrod performance status 0-1

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL

- Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 60
mL/min

- Urine protein: creatinine ratio < 1 OR urine protein < 500 mg by 24-hour urine
collection

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Willing to provide smoking history

- No evidence of active infection

- No active bleeding

- No significant history of bleeding diathesis, including hemoptysis (½ teaspoon of
hemoptysis within the past 3 months), or underlying coagulopathy

- No history of recent arterial embolic events, including any of the following:

- Myocardial infarction

- Cerebrovascular accident

- Transient ischemic attack

- Worsening of pre-existing angina within the past 6 months

- No uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg)

- History of hypertension allowed provided it is controlled on anti-hypertensive
medications

- No history of congestive heart failure

- No history of encephalitis or encephalopathy of any cause

- No diverticulitis, gastrointestinal bleeding, or peptic ulcer within the past 3
months

- No known AIDS or HIV-1 associated complex

- No known history of immune or immunodeficiency disorders

- No unstable or pre-existing major medical conditions except for cancer-related
abnormalities

- No other prior malignancy except for any of the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I or II cancer currently in complete remission

- Any other cancer from which the patient been disease-free for 5 years

- Concurrent chronic therapeutic doses of low molecular weight heparin allowed

- At least 21 days since prior and no concurrent radiotherapy and recovered

- At least 28 days since prior and no concurrent surgery (e.g., thoracic or other major
surgeries) and recovered

- No prior bevacizumab or other anti-angiogenic therapies including, but not limited
to, small molecule tyrosine kinase inhibitors

- No concurrent enzyme-inducing anticonvulsant drugs

- Non-enzyme-inducing anticonvulsant drugs (e.g., Keppra) allowed

- Concurrent chronic oral anticoagulation therapy allowed provided INR is maintained in
the therapeutic range (INR 2-3)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 months

Safety Issue:

No

Principal Investigator

Jeffrey Allen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group (SWOG) Research Base

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-01182

NCT ID:

NCT00828139

Start Date:

May 2009

Completion Date:

Related Keywords:

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

Name

Location

Baylor College of MedicineHouston, Texas  77030
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
University of Washington Medical CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Loyola University Medical CenterMaywood, Illinois  60153
South Georgia Medical CenterValdosta, Georgia  31603
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Akron General Medical CenterAkron, Ohio  44302
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Via Christi Regional Medical CenterWichita, Kansas  67214
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Scott and White Memorial HospitalTemple, Texas  76508
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Winthrop University HospitalMineola, New York  11501
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Big Sky OncologyGreat Falls, Montana  59405
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Adena Regional Medical CenterChillicothe, Ohio  54601
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
City of Hope Medical CenterDuarte, California  91010
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
Gwinnett Medical CenterLawrenceville, Georgia  30045
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
Mecosta County Medical CenterBig Rapids, Michigan  49307
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Iredell Memorial HospitalStatesville, North Carolina  28677
Grandview HospitalDayton, Ohio  45405
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Danville Regional Medical CenterDanville, Virginia  24541
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Highland General HospitalOakland, California  94602
Randolph HospitalAsheboro, North Carolina  27203
Miami Valley HospitalDayton, Ohio  45409
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Hospital District Sixth of Harper CountyAnthony, Kansas  67003
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Northern Montana HospitalHavre, Montana  59501
Mary Rutan HospitalBellefontaine, Ohio  43311
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Clinton Memorial HospitalWilmington, Ohio  45177
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Singing River HospitalPascagoula, Mississippi  39581
Ben Taub General HospitalHouston, Texas  77030
Methodist HospitalHouston, Texas  77030
Greene Memorial HospitalXenia, Ohio  45385
Rutherford HospitalRutherfordton, North Carolina  28139
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Memorial Medical CenterSpringfield, Illinois  62781
McLeod Regional Medical CenterFlorence, South Carolina  29501
Metro Health HospitalGrand Rapids, Michigan  49506
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Providence HospitalMobile, Alabama  36608
Northwest Cancer SpecialistsVancouver, Washington  98664
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Larry G Strieff MD Medical CorporationOakland, California  94609
Saint Louis University HospitalSt. Louis, Missouri  63110-0250
University of RochesterRochester, New York  14642
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Southwest Washington Medical CenterVancouver, Washington  98664
El Camino HospitalMountain View, California  94040
High Point Regional HospitalHigh Point, North Carolina  27261
Wayne State UniversityDetroit, Michigan  48202
University of Arizona Health Sciences CenterTucson, Arizona  85724
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Providence Portland Medical CenterPortland, Oregon  97213-3635
Columbus CCOPColumbus, Ohio  43206
University of KentuckyLexington, Kentucky  40536-0098
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
UC Davis Comprehensive Cancer CenterSacramento, California  95817
Oregon Health and Science UniversityPortland, Oregon  97201
Decatur Memorial HospitalDecatur, Illinois  62526
Louisiana State University Health Science CenterNew Orleans, Louisiana  70112
Mount Carmel Regional Cancer CenterPittsburg, Kansas  66762
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Memorial Health University Medical CenterSavannah, Georgia  31404
DeKalb Medical CenterDecatur, Georgia  30033
Rockwood ClinicSpokane, Washington  99220
University of CincinnatiCincinnati, Ohio  45267-0502
San Luis Valley Regional Medical CenterAlamosa, Colorado  81101
Valley View Hospital Cancer CenterGlenwood Springs, Colorado  81601
Piedmont Fayette HospitalFayetteville, Georgia  30214
Hays Medical CenterHays, Kansas  67601
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
Providence Newberg Medical CenterNewberg, Oregon  97132
Northside HospitalAtlanta, Georgia  30342
Highlands Oncology Group-BentonvilleBentonville, Arkansas  72712
Valley Medical Oncology Consultants-Castro ValleyCastro Valley, California  94546
Eden Hospital Medical CenterCastro Valley, California  94546
Valley Medical Oncology Consultants-FremontFremont, California  94538
Fremont - Rideout Cancer CenterMarysville, California  95901
Bay Area Breast Surgeons IncOakland, California  94609
Bay Area Tumor Institution CCOPOakland, California  94609
Tom K Lee IncOakland, California  94609
Valley Medical Oncology ConsultantsPleasanton, California  94588
Valley Care Health System - PleasantonPleasanton, California  94588
Doctors Medical Center- JC Robinson Regional Cancer CenterSan Pablo, California  94806
Saint Mary's Hospital and Regional Medical CenterGrand Junction, Colorado  81502
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Atlanta Regional CCOPAtlanta, Georgia  30342
Well Star Cobb HospitalAustell, Georgia  30106
John B Amos Cancer CenterColumbus, Georgia  31904
Wellstar Kennestone HospitalMarietta, Georgia  30060
Saint Anthony's HealthAlton, Illinois  62002
Good Samaritan Regional Medical CenterMt. Vernon, Illinois  62864
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
Genesis Medical Center - East CampusDavenport, Iowa  52803
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Stormont-Vail Regional Health CenterTopeka, Kansas  66604
Saint Francis Hospital and Medical Center - TopekaTopeka, Kansas  66606
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Medical Center of LouisianaNew Orleans, Louisiana  70112
Holy Family HospitalMethuen, Massachusetts  01844
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Saint Mary's Health CareGrand Rapids, Michigan  49503
Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Health Partners-Mercy CampusMuskegon, Michigan  49443
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Kansas City Veterans Affairs Medical CenterKansas City, Missouri  64128
Truman Medical CenterKansas City, Missouri  64108
Saint Louis-Cape Girardeau CCOPSaint Louis, Missouri  63141
Saint John's Mercy Medical CenterSaint Louis, Missouri  63141
Saint Louis Cancer and Breast InstituteSaint Louis, Missouri  63109
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
Saint John's HospitalSpringfield, Missouri  65804
Cox Medical CenterSpringfield, Missouri  65807
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Columbia University Medical CenterNew York, New York  10032
Interlakes Foundation Inc-RochesterRochester, New York  14623
Highland HospitalRochester, New York  14620
Gaston Memorial HospitalGastonia, North Carolina  28054
Wayne Memorial HospitalGoldsboro, North Carolina  27534
Margaret R Pardee Memorial HospitalHendersonville, North Carolina  28791
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Marietta Memorial HospitalMarietta, Ohio  45750
Upper Valley Medical CenterTroy, Ohio  45373
Saint Ann's HospitalWesterville, Ohio  43081
Wright-Patterson Medical CenterWright-Patterson Afb, Ohio  45433-5529
Genesis HealthCare SystemZanesville, Ohio  43701
Providence Saint Vincent Medical CenterPortland, Oregon  97225
Columbia River Oncology ProgramPortland, Oregon  97225
Salem HospitalSalem, Oregon  97309
AnMed Health HospitalAnderson, South Carolina  29621
Upstate Carolina CCOPSpartanburg, South Carolina  29303
Veterans Administration Medical CenterHouston, Texas  77030
Saint Luke's Episcopal HospitalHouston, Texas  77030
Saint Joseph HospitalBellingham, Washington  98225
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Olathe Cancer CenterOlathe, Kansas  66061
Lahey Clinic Medical CenterBurlington, Massachusetts  01805
NEA Medical CenterJonesboro, Arkansas  72401
University of Colorado Cancer Center - Anschutz Cancer PavilionAurora, Colorado  80045
The Shaw Regional Cancer CenterEdwards, Colorado  81632
Montrose Memorial HospitalMontrose, Colorado  81401
Harbin Clinic Medical Oncology and Clinical ResearchRome, Georgia  30165
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
University of Michigan University HospitalAnn Arbor, Michigan  48109
Carolinas Medical Center - NortheastConcord, North Carolina  28025
Moses Cone Health System-Regional Cancer CenterGreensboro, North Carolina  27403
Annie Penn Memorial HospitalReidsville, North Carolina  27320
University of Tennessee - KnoxvilleKnoxville, Tennessee  37920
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Texas Tech University Health Sciences CenterLubbock, Texas  79430
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719
Arizona Cancer Center at UMC Orange GroveTucson, Arizona  85704
Kansas City Cancer Center-WestKansas City, Kansas  66112
Salina Regional Health Center.Salina, Kansas  67401
Arnot Ogden Medical CenterElmira, New York  14905
Southern Ohio Medical CenterPortsmouth, Ohio  45662
Willamette Falls Community HospitalOregon City, Oregon  97045
University of Tennessee - MemphisMemphis, Tennessee  38163
Memorial Hospital Of MartinsvilleMartinsville, Virginia  24115
Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center-Main CampusBurien, Washington  98166
United General HospitalSedro-Woolley, Washington  98284
Cancer Care Center of DecaturDecatur, Illinois  62526
Gulfport Memorial HospitalGulfport, Mississippi  39502
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Bronson Battle CreekBattle Creek, Michigan  49017
Springfield Regional Medical CenterSpringfield, Ohio  45505
Promise Regional Medical Center-HutchinsonHutchinson, Kansas  65702
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370