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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 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
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Southern Regional Medical CenterRiverdale, Georgia  30274-2600
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Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
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Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Singing River HospitalPascagoula, Mississippi  39581
Ben Taub General HospitalHouston, Texas  77030
Methodist HospitalHouston, Texas  77030
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Rutherford HospitalRutherfordton, North Carolina  28139
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Reid Hospital and Health Care ServicesRichmond, Indiana  47374
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Saint John's Mercy Medical CenterSaint Louis, Missouri  63141
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Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
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Kansas City Cancer Center-WestKansas City, Kansas  66112
Salina Regional Health Center.Salina, Kansas  67401
Arnot Ogden Medical CenterElmira, New York  14905
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University of Tennessee - MemphisMemphis, Tennessee  38163
Memorial Hospital Of MartinsvilleMartinsville, Virginia  24115
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Highline Medical Center-Main CampusBurien, Washington  98166
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