Phase I / Randomized Phase II Study of Second Line Therapy With Irinotecan and Cetuximab With or Without RAD001, an Oral mTOR Inhibitor for Patients With Metastatic Colorectal Cancer: Hoosier Oncology Group GI05-102
OUTLINE: This is a multi-center study.
PHASE I:
- UGT1A1 *28 7/7 genotype IS NOT present
- Cetuximab 250 mg/m2 IV days 1, 8, and 15
- Irinotecan 125 mg/m2 IV days 1 and 8
- RAD001 PO QD (dose determined at the time of registration; subjects will remain at this
dose level until treatment discontinuation)
PHASE II:
- Randomization based on UGT1A1 *28 7/7 Genotype or Prior Irinotecan Exposure
ARM A:
- Cetuximab 250 mg/m2 IV days 1, 8, and 15
- Irinotecan 125 mg/m2 IV days 1 and 8
AT TIME OF PROGRESSIVE DISEASE, ARM A TREATMENT WILL CROSSOVER:
- Cetuximab 250 mg/m2 IV days 1, 8, and 15
- Irinotecan 125 mg/m2 IV days 1 and 8
- RAD001 PO QD (maximum tolerated dose)
ARM B:
- Cetuximab 250 mg/m2 IV days 1, 8, and 15
- Irinotecan 125 mg/m2 IV days 1 and 8
- RAD001 PO QD (maximum tolerated dose)
AT TIME OF PROGRESSIVE DISEASE, ARM B TREATMENT WILL BE DISCONTINUED
ECOG performance status 0-2
Life Expectancy: Not specified
Hematopoietic:
- Absolute neutrophil count (ANC) ≥ 1,500 mm3
- Platelets ≥ 100,000 mm3
- Hemoglobin (Hgb) ≥ 9 g/dL
- White blood cell count (WBC) ≥ 2,000 mm3
- INR < 1.5 x upper limit of normal (ULN) if not on anticoagulation (if on
anticoagulation must have an in-range INR (usually between 2 and 3) on a stable dose of
warfarin)
- PTT < 1.5 x ULN
Hepatic:
- Bilirubin ≤ 1.5 x ULN
- Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN
- Albumin ≥ 3.0 g/dL
Renal:
- Calculated creatinine clearance of ≥ 60 cc/min using the Cockcroft-Gault formula
Cardiovascular:
- No uncontrolled cardiac arrhythmia requiring medication, transient ischemic attack
(TIA), or cerebrovascular accident (CVA) within 6 months prior to being registered for
protocol therapy
- No uncontrolled congestive heart failure, myocardial infarction, or unstable angina
within 6 months prior to being registered for protocol therapy
Pulmonary:
- No severely impaired lung function as demonstrated by pulse O2 saturation ≤ 90% at rest
on room air, or pulmonary function test FEV1 ≤ 2L
- No history of prior chronic lung infection such as tuberculosis, atypical tuberculosis,
or histoplasmosis as evidenced by a chest CT or x-ray within 21 days prior to being
registered for protocol therapy
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the MTD of RAD001 in combination with irinotecan and cetuximab as second line therapy in patients with metastatic colorectal cancer
Phase I
Yes
Gabriela Chiorean, M.D.
Study Chair
Hoosier Oncology Group, Inc.
United States: Food and Drug Administration
GI05-102
NCT00522665
August 2007
June 2013
Name | Location |
---|---|
Siteman Cancer Center | Saint Louis, Missouri 63110 |
Northwestern University Feinberg School of Medicine | Chicago, Illinois 60611 |
Arnett Cancer Care | Lafayette, Indiana 47904 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Medical & Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Horizon Oncology Center | Lafayette, Indiana 47905 |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
Community Regional Cancer Center | Indianapolis, Indiana 46256 |
Center for Cancer Care, Inc., P.C. | New Albany, Indiana 47150 |
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 |