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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)

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Trial Conditions
  • Lung Cancer
  • Extensive Stage Small Cell Lung Cancer
  • Recurrent Small Cell Lung Cancer
What is the purpose of this trial?

RATIONALE: 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. PURPOSE: 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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

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

- At least 28 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)

- Concurrent chronic therapeutic doses of low molecular weight heparin allowed

Gender: Both
Steward Physician(s)
  • Jeffrey Allen
  • Shirish M. Gadgeel, MD
Facilities
  • Holy Family Hospital - Active, not recruiting
Trial Interventions
Biological
  • ziv-aflibercept
Drug
  • topotecan hydrochloride
Physician Researcher

Investigator Name:

  • Jeffrey Allen
  • Shirish M. Gadgeel, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00828139
Volunteers:  Not Accepting Healthy Volunteers

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