A Phase I Study of Amrubicin and Cyclophosphamide in Patients With Advanced Solid Organ Malignancies
OUTLINE: This is a multi-center study.
This study will follow the 3+3 design with the following dose levels:
- Dose Level -1: Amrubicin 20mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 1: Amrubicin 25mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 2: Amrubicin 30mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 3: Amrubicin 35mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 4: Amrubicin 40mg/m2, Cyclophosphamide 500mg/m2
Dose escalation starts from dose level 1.
Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once
daily for 3 consecutive days starting on day 1 of each 21 day cycle.
Cyclophosphamide will be given at a fixed dose as an IV infusion over 30-60 minutes on day 1
of each 21 day cycle (following amrubicin).
ECOG Performance Status: 0-1
Life expectancy: not specified
Hematopoietic:
- Hemoglobin (Hgb) > 9 g/dL.
- Platelets > 100 K/mm3
- Absolute Neutrophil Count (ANC) > 1.5 K/mm3
Hepatic:
- Aspartate transaminase (AST) ≤ 2.5 x ULN
- Alanine transaminase (ALT) ≤ 2.5 x ULN
- Total bilirubin < 1.5 x ULN
Renal:
- Calculated creatinine clearance ≥ 60cc/min
Cardiovascular:
- Left Ventricular Ejection Fraction (LVEF) ≥ LLN for institution within 60 days prior to
registration for protocol therapy.
- No history of cardiomyopathy or uncontrolled heart arrhythmia.
Pulmonary:
- No suspected, diffuse idiopathic interstitial lung disease or history of pulmonary
fibrosis.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of the combination of amrubicin and cyclophosphamide in patients with advanced solid tumors.
24 months
Yes
Lawrence Einhorn, M.D.
Principal Investigator
Hoosier Oncology Group
United States: Food and Drug Administration
HOG LUN07-130
NCT00890955
March 2009
July 2010
Name | Location |
---|---|
Highlands Oncology Group | Springdale, Arkansas 72764 |
Siteman Cancer Center | Saint Louis, Missouri 63110 |
Helen F. Graham Cancer Center | Newark, Delaware 19713 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Medical & Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Medical Consultants, P.C. | Muncie, Indiana 47303 |
Fox Chase Cancer Center Extramural Research Program | Rockledge, Pennsylvania 19046 |
Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |