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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
Open (Enrolling)
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)


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.


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

- 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

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

- 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

- 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

- 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

- 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:


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:


Principal Investigator

Jeffrey Allen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group (SWOG) Research Base


United States: Food and Drug Administration

Study ID:




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



Baylor College of Medicine Houston, Texas  77030
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
University of Washington Medical Center Seattle, Washington  98195-6043
Hurley Medical Center Flint, Michigan  48503
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Loyola University Medical Center Maywood, Illinois  60153
South Georgia Medical Center Valdosta, Georgia  31603
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
Akron General Medical Center Akron, Ohio  44302
University of Texas Medical Branch Galveston, Texas  77555-1329
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Via Christi Regional Medical Center Wichita, Kansas  67214
Carolinas Medical Center Charlotte, North Carolina  28232-2861
Scott and White Memorial Hospital Temple, Texas  76508
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
Group Health Cooperative Seattle, Washington  98112
Great Falls Clinic Great Falls, Montana  59405
Winthrop University Hospital Mineola, New York  11501
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
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
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
Big Sky Oncology Great Falls, Montana  59405
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Adena Regional Medical Center Chillicothe, Ohio  54601
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Harborview Medical Center Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Welch Cancer Center Sheridan, Wyoming  82801
City of Hope Medical Center Duarte, California  91010
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Piedmont Hospital Atlanta, Georgia  30309
Gwinnett Medical Center Lawrenceville, Georgia  30045
Southern Regional Medical Center Riverdale, Georgia  30274-2600
Mecosta County Medical Center Big Rapids, Michigan  49307
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Iredell Memorial Hospital Statesville, North Carolina  28677
Grandview Hospital Dayton, Ohio  45405
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Danville Regional Medical Center Danville, Virginia  24541
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Highland General Hospital Oakland, California  94602
Randolph Hospital Asheboro, North Carolina  27203
Miami Valley Hospital Dayton, Ohio  45409
Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Hospital District Sixth of Harper County Anthony, Kansas  67003
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Northern Montana Hospital Havre, Montana  59501
Mary Rutan Hospital Bellefontaine, Ohio  43311
Wayne Hospital Greenville, Ohio  45331
Knox Community Hospital Mount Vernon, Ohio  43050
Clinton Memorial Hospital Wilmington, Ohio  45177
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
Baton Rouge General Medical Center Baton Rouge, Louisiana  70821-2511
Singing River Hospital Pascagoula, Mississippi  39581
Ben Taub General Hospital Houston, Texas  77030
Methodist Hospital Houston, Texas  77030
Greene Memorial Hospital Xenia, Ohio  45385
Rutherford Hospital Rutherfordton, North Carolina  28139
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Memorial Medical Center Springfield, Illinois  62781
McLeod Regional Medical Center Florence, South Carolina  29501
Metro Health Hospital Grand Rapids, Michigan  49506
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Providence Hospital Mobile, Alabama  36608
Northwest Cancer Specialists Vancouver, Washington  98664
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
Saint Louis University Hospital St. Louis, Missouri  63110-0250
University of Rochester Rochester, New York  14642
Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Southwest Washington Medical Center Vancouver, Washington  98664
El Camino Hospital Mountain View, California  94040
High Point Regional Hospital High Point, North Carolina  27261
Wayne State University Detroit, Michigan  48202
University of Arizona Health Sciences Center Tucson, Arizona  85724
Riverside Methodist Hospital Columbus, Ohio  43214
Licking Memorial Hospital Newark, Ohio  43055-2899
Providence Portland Medical Center Portland, Oregon  97213-3635
Columbus CCOP Columbus, Ohio  43206
University of Kentucky Lexington, Kentucky  40536-0098
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
UC Davis Comprehensive Cancer Center Sacramento, California  95817
Oregon Health and Science University Portland, Oregon  97201
Decatur Memorial Hospital Decatur, Illinois  62526
Louisiana State University Health Science Center New Orleans, Louisiana  70112
Mount Carmel Regional Cancer Center Pittsburg, Kansas  66762
Montana Cancer Specialists Missoula, Montana  59807-7877
Memorial Health University Medical Center Savannah, Georgia  31404
DeKalb Medical Center Decatur, Georgia  30033
Rockwood Clinic Spokane, Washington  99220
University of Cincinnati Cincinnati, Ohio  45267-0502
San Luis Valley Regional Medical Center Alamosa, Colorado  81101
Valley View Hospital Cancer Center Glenwood Springs, Colorado  81601
Piedmont Fayette Hospital Fayetteville, Georgia  30214
Hays Medical Center Hays, Kansas  67601
Clackamas Radiation Oncology Center Clackamas, Oregon  97015
Providence Newberg Medical Center Newberg, Oregon  97132
Northside Hospital Atlanta, Georgia  30342
Highlands Oncology Group-Bentonville Bentonville, Arkansas  72712
Valley Medical Oncology Consultants-Castro Valley Castro Valley, California  94546
Eden Hospital Medical Center Castro Valley, California  94546
Valley Medical Oncology Consultants-Fremont Fremont, California  94538
Fremont - Rideout Cancer Center Marysville, California  95901
Bay Area Breast Surgeons Inc Oakland, California  94609
Bay Area Tumor Institution CCOP Oakland, California  94609
Tom K Lee Inc Oakland, California  94609
Valley Medical Oncology Consultants Pleasanton, California  94588
Valley Care Health System - Pleasanton Pleasanton, California  94588
Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo, California  94806
Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado  81502
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Atlanta Regional CCOP Atlanta, Georgia  30342
Well Star Cobb Hospital Austell, Georgia  30106
John B Amos Cancer Center Columbus, Georgia  31904
Wellstar Kennestone Hospital Marietta, Georgia  30060
Saint Anthony's Health Alton, Illinois  62002
Good Samaritan Regional Medical Center Mt. Vernon, Illinois  62864
Saint Francis Hospital and Health Centers Beech Grove, Indiana  46107
Reid Hospital and Health Care Services Richmond, Indiana  47374
Genesis Medical Center - East Campus Davenport, Iowa  52803
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
Stormont-Vail Regional Health Center Topeka, Kansas  66604
Saint Francis Hospital and Medical Center - Topeka Topeka, Kansas  66606
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Medical Center of Louisiana New Orleans, Louisiana  70112
Holy Family Hospital Methuen, Massachusetts  01844
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
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Saint Mary's Health Care Grand Rapids, Michigan  49503
Spectrum Health at Butterworth Campus Grand Rapids, Michigan  49503
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Mercy Health Partners-Mercy Campus Muskegon, Michigan  49443
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
Kansas City Veterans Affairs Medical Center Kansas City, Missouri  64128
Truman Medical Center Kansas City, Missouri  64108
Saint Louis-Cape Girardeau CCOP Saint Louis, Missouri  63141
Saint John's Mercy Medical Center Saint Louis, Missouri  63141
Saint Louis Cancer and Breast Institute Saint Louis, Missouri  63109
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Springfield, Missouri  65802
Saint John's Hospital Springfield, Missouri  65804
Cox Medical Center Springfield, Missouri  65807
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Billings Clinic Billings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment Center Butte, Montana  59701
Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana  59405
Berdeaux, Donald MD (UIA Investigator) Great Falls, Montana  59405
Saint Peter's Community Hospital Helena, Montana  59601
Glacier Oncology PLLC Kalispell, Montana  59901
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Nevada Cancer Research Foundation CCOP Las Vegas, Nevada  89106
Columbia University Medical Center New York, New York  10032
Interlakes Foundation Inc-Rochester Rochester, New York  14623
Highland Hospital Rochester, New York  14620
Gaston Memorial Hospital Gastonia, North Carolina  28054
Wayne Memorial Hospital Goldsboro, North Carolina  27534
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina  28791
Doctors Hospital Columbus, Ohio  43228
Grant Medical Center Columbus, Ohio  43215
Mount Carmel Health Center West Columbus, Ohio  43222
Good Samaritan Hospital - Dayton Dayton, Ohio  45406
Dayton CCOP Dayton, Ohio  45429
Samaritan North Health Center Dayton, Ohio  45415
Blanchard Valley Hospital Findlay, Ohio  45840
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio  45005-1066
Kettering Medical Center Kettering, Ohio  45429
Marietta Memorial Hospital Marietta, Ohio  45750
Upper Valley Medical Center Troy, Ohio  45373
Saint Ann's Hospital Westerville, Ohio  43081
Wright-Patterson Medical Center Wright-Patterson Afb, Ohio  45433-5529
Genesis HealthCare System Zanesville, Ohio  43701
Providence Saint Vincent Medical Center Portland, Oregon  97225
Columbia River Oncology Program Portland, Oregon  97225
Salem Hospital Salem, Oregon  97309
AnMed Health Hospital Anderson, South Carolina  29621
Upstate Carolina CCOP Spartanburg, South Carolina  29303
Veterans Administration Medical Center Houston, Texas  77030
Saint Luke's Episcopal Hospital Houston, Texas  77030
Saint Joseph Hospital Bellingham, Washington  98225
Harrison Bremerton Hematology and Oncology Bremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLC Kennewick, Washington  99336
Minor and James Medical PLLC Seattle, Washington  98104
The Polyclinic Seattle, Washington  98122
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
Olathe Cancer Center Olathe, Kansas  66061
Lahey Clinic Medical Center Burlington, Massachusetts  01805
NEA Medical Center Jonesboro, Arkansas  72401
University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora, Colorado  80045
The Shaw Regional Cancer Center Edwards, Colorado  81632
Montrose Memorial Hospital Montrose, Colorado  81401
Harbin Clinic Medical Oncology and Clinical Research Rome, Georgia  30165
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
University of Michigan University Hospital Ann Arbor, Michigan  48109
Carolinas Medical Center - Northeast Concord, North Carolina  28025
Moses Cone Health System-Regional Cancer Center Greensboro, North Carolina  27403
Annie Penn Memorial Hospital Reidsville, North Carolina  27320
University of Tennessee - Knoxville Knoxville, Tennessee  37920
Skagit Valley Hospital Mt. Vernon, Washington  98273
Evergreen Hematology and Oncology PS Spokane, Washington  99218
Texas Tech University Health Sciences Center Lubbock, Texas  79430
Arizona Cancer Center at University Medical Center North Tucson, Arizona  85719
Arizona Cancer Center at UMC Orange Grove Tucson, Arizona  85704
Kansas City Cancer Center-West Kansas City, Kansas  66112
Salina Regional Health Center. Salina, Kansas  67401
Arnot Ogden Medical Center Elmira, New York  14905
Southern Ohio Medical Center Portsmouth, Ohio  45662
Willamette Falls Community Hospital Oregon City, Oregon  97045
University of Tennessee - Memphis Memphis, Tennessee  38163
Memorial Hospital Of Martinsville Martinsville, Virginia  24115
Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center-Main Campus Burien, Washington  98166
United General Hospital Sedro-Woolley, Washington  98284
Cancer Care Center of Decatur Decatur, Illinois  62526
Gulfport Memorial Hospital Gulfport, Mississippi  39502
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Bronson Battle Creek Battle Creek, Michigan  49017
Springfield Regional Medical Center Springfield, Ohio  45505
Promise Regional Medical Center-Hutchinson Hutchinson, Kansas  65702
Harrison Poulsbo Hematology and Oncology Poulsbo, Washington  98370