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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Extensive Stage Small Cell Lung Cancer

Recurrent Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 che...

Detailed Description

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 st...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    May 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2012

    Estimated Enrollment :

    189 Patients enrolled

    Trial Details

    Trial ID

    NCT00828139

    Start Date

    May 1 2009

    End Date

    September 1 2012

    Last Update

    August 21 2017

    Active Locations (257)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 65 (257 locations)

    1

    Northeast Alabama Regional Medical Center

    Anniston, Alabama, United States, 36202

    2

    Providence Hospital

    Mobile, Alabama, United States, 36608

    3

    Arizona Cancer Center at UMC Orange Grove

    Tucson, Arizona, United States, 85704

    4

    Arizona Cancer Center at University Medical Center North

    Tucson, Arizona, United States, 85719