A Randomized Double Blind Phase II Trial of Cisplatin Plus Etoposide With/Without Concurrent ZD6474 in Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer: Hoosier Oncology Group LUN06-113
OUTLINE: This is a multi-center study.
Arm A:
Cisplatin 60mg/m2 Day 1 + Etoposide 120mg/m2 Day 1,2,3 + Placebo oral daily given
continuously for the duration of the study
Arm B:
Cisplatin 60mg/m2 Day 1 + Etoposide 120mg/m2 Day 1,2,3 + ZD6474 100mg oral daily given
continuously for the duration of the study
For both arms, PE and toxicity evaluation prior to each cycle and disease assessment by
imaging every 2 cycles. Patients with non-PD and acceptable toxicity will continue protocol
therapy; patients with progressive disease or excessive toxicity will be taken off
treatment. Cycles will be repeated every 21 days up to a total of 4 cycles.
ECOG Performance Status of 0 or 1
Life Expectancy: Not specified
Hematopoietic:
- Platelets > 100K/mm3
- Absolute neutrophil count (ANC) > 1.5K/mm3
Hepatic:
- Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST) < 2.5 x ULN or < 5 x ULN if judged by the
investigator to be related to liver metastases
- Alkaline phosphatase < 2.5 x ULN or < 5 x ULN if judged by the investigator to be
related to liver metastases
Renal:
- Serum creatinine < 1.5 x ULN or Calculated creatinine clearance of > 45 cc/min using
the Cockcroft-Gault formula
Cardiovascular:
- No clinically significant cardiac event such as myocardial infarction; New York Heart
Association (NYHA) classification of heart disease >2 (see SPM) within 3 months prior
to registration for protocol therapy
- No presence of cardiac disease that, in the opinion of the Investigator, increases the
risk of ventricular arrhythmia.
- No history of arrhythmia (multifocal premature ventricular contractions (PVCs),
bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation)
which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained
ventricular tachycardia. Atrial fibrillation, controlled on medication is permitted.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
The primary objective will be to evaluate whether the addition of ZD6474 to EP improves time to disease progression over EP alone.
24 months
No
Nasser Hanna, M.D.
Study Chair
Hoosier Oncology Group, Inc.
United States: Food and Drug Administration
LUN06-113
NCT00613626
January 2008
January 2014
Name | Location |
---|---|
Helen F. Graham Cancer Center | Newark, Delaware 19713 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Northwestern University Feinberg School of Medicine | Chicago, Illinois 60611 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Medical & Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
Providence Medical Group | Terre Haute, Indiana 47802 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
Hematology Oncology Associates S.J., P.A. | Mt. Holly, New Jersey 08060 |
Pennsylvania Oncology-Hematology Associates | Philadelphia, Pennsylvania 19106 |
Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |
IN Onc/Hem Associates | Indianapolis, Indiana 46202 |
St. Vincent Hospital & Health Centers | Indianapolis, Indiana 46206 |
Monroe Medical Associates | Munster, Indiana 46321 |
Horizon Oncology Researcg | Lafayette, Indiana 47905 |
IU Health Arnett Cancer Center | Lafayette, Indiana 47904 |
IU Health at Ball Memorial Hospital | Muncie, Indiana 47303 |