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

Completed · Phase 2

Conditions studied: Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00828139

Run by

National Cancer Institute (NCI)

People needed

189

Starts

2009-05-01

Expected to finish

2012-09-01

Last updated by the study team

2017-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• Providence Hospital — Mobile, Alabama, United States
• Arizona Cancer Center at UMC Orange Grove — Tucson, Arizona, United States
• Arizona Cancer Center at University Medical Center North — Tucson, Arizona, United States
• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• NEA Baptist Memorial Hospital — Jonesboro, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Highlands Oncology Group-Rogers — Rogers, Arkansas, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• City of Hope Medical Center — Duarte, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• El Camino Hospital — Mountain View, California, United States
• Highland General Hospital — Oakland, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Breast Surgeons Inc — Oakland, California, United States
• Bay Area Tumor Institute CCOP — Oakland, California, United States
• Larry G Strieff MD Medical Corporation — Oakland, California, United States
• Tom K Lee Inc — Oakland, California, United States
• Valley Care Health System - Pleasanton — Pleasanton, California, United States
• Valley Medical Oncology Consultants — Pleasanton, California, United States
• University of California at Davis Cancer Center — Sacramento, California, United States
• Northeast Alabama Regional Medical Center — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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