S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2009
End Date:June 2012

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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)

This randomized phase II trial is studying topotecan to see how well it works when given
with or without aflibercept in treating patients with extensive-stage small cell lung
cancer. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Combinations of biological substances in aflibercept may be able to carry tumor-killing
substances directly to small cell lung cancer cells. Aflibercept may also stop the growth of
small cell lung cancer by blocking blood flow to the tumor. It is not yet known whether
topotecan is more effective with or without aflibercept in treating patients with small cell
lung cancer.

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)
We found this trial at
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1 Hurley Plaza
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1200 Moursund Street
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2500 N State St
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529 West Markham Street
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4805 Northeast Glisan Street
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3181 Southwest Sam Jackson Park Road
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503 494-8311
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60 Crittenden Blvd # 70
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2279 45th Street
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500 S State St
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