A Phase I/II Study of Sorafenib in Combination With Topotecan for the Treatment of Platinum-Resistant Recurrent Ovarian Cancer or Primary Peritoneal Carcinomatosis: Hoosier Oncology Group GYN06-111
OUTLINE: This is a multi-center study.
- Topotecan: 4mg/m2 weekly, 3 weeks on and one week off.
- Sorafenib: Assigned cohort dose for phase I (up to 12 patients) Maximum tolerated dose
for phase II (21 total patients)
Cycles will consist of 4 weeks (28 days) with disease evaluations every 8 weeks.
Non-PD and acceptable toxicity: Patients will continue protocol therapy PD or unacceptable
toxicity: Patients will discontinue protocol therapy
ECOG performance status 0-1
Life expectancy: Three (3) months
Hematopoietic:
- White blood cell count (WBC) > 3 K/mm3
- Hemoglobin (Hgb) > 9 g/dL
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) > 1.5 K/mm3
- INR < 1.5 or a PTT within normal limits. NOTE: Patients receiving anti-coagulation
treatment with an agent such as warfarin or heparin may be allowed to participate.
- No evidence or history of bleeding diathesis or coagulopathy.
Hepatic:
- Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST, SGOT) < 2.5 x ULN
- Alanine aminotransferase (ALT, SGPT) < 2.5 x ULN
- Alkaline phosphate < 2.5 x ULN
Renal:
- Creatinine < 1.5 x ULN
Cardiovascular:
- No history of myocardial infarction or angina pectoris or angina equivalent within 6
months prior to registration for protocol therapy (the patient may not be on
anti-anginal or anti-arrhythmic medications), or have uncontrolled hypertension or
congestive heart failure > class II NYHA
Pulmonary:
- No thrombolic or embolic events such as a cerebrovascular accident, including transient
ischemic attacks within the past 6 months.
- No pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 28 days prior to
registration for protocol therapy.
- No non-pulmonary hemorrhage/bleeding event > CTCAE Grade 3 within 28 days prior to
registration for protocol therapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To find the maximum tolerated dose (MTD) for the phase II component and evaluate the safety and toxicity of the combination Sorafenib plus Topotecan in patients with recurrent or resistant epithelial ovarian cancer.
Phase I
Yes
Daniela Matei, M.D.
Study Chair
Hoosier Oncology Group, Inc.
United States: Institutional Review Board
GYN06-111
NCT00526799
September 2007
August 2010
Name | Location |
---|---|
Arnett Cancer Care | Lafayette, Indiana 47904 |
Medical & Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
Medical Consultants, P.C. | Muncie, Indiana 47303 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
Schwartz Gynecologic Oncology, PLLC | Babylon, New York 11702 |
Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |
St. Vincent Hospital Cynecologic Oncology | Indianapolis, Indiana 46260 |