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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

Phase 1/Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

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


- 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.


- 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


- Creatinine < 1.5 x ULN


- 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


- 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.

Inclusion Criteria:

- Have histologically-confirmed epithelial ovarian cancer, primary peritoneal
carcinomatosis or fallopian tube cancer. Enrollment of patients with clear cell
histology is encouraged.

- Have measurable disease according to RECIST or detectable disease by 1) CA-125 at
least twice the ULN within 14 days prior to registration for protocol therapy; 2)
Ascites and/or pleural effusion attributed to tumor; 3) solid and/or cystic
abnormalities on radiographic imaging that do not meet RECIST definitions for target

- Have failed at least one prior platinum based chemotherapeutic regimen.

- No more than 3 prior treatment regimens for epithelial ovarian cancer.

- Prior radiation therapy is allowed to < 25% of the bone marrow.

- Be at least 4 weeks since last anti-cancer treatment, radiation or surgery at the
time of registration for protocol therapy.

- No active cancer in addition to the epithelial ovarian cancer within the last 5
years, with the exception of: superficial skin cancer (basal cell or squamous cell
skin carcinoma; carcinoma in situ of the cervix; Stage I endometrial cancer with less
than 50% invasion of the myometrium, or other adequately treated Stage I or II cancer
in complete remission.

- Age > 18 years at the time of consent

- Written informed consent and HIPAA authorization for release of personal health

- Females of childbearing potential must be willing to use an effective method of
contraception (hormonal or barrier method of birth control; abstinence) from the time
consent is signed until 90 days after treatment discontinuation

- Females of childbearing potential must have a negative pregnancy test within 7 days
prior to being registered for protocol therapy.

Exclusion Criteria:

- No known or suspected allergy to sorafenib or any agent given in the course of this

- No prior treatment with anti-angiogenesis therapy.

- No active CNS metastases.

- No treatment with any investigational agent within 30 days prior to being registered
for protocol therapy.

- No concurrent combination anti-retroviral therapy for the treatment of

- No clinically significant infections requiring antibiotic treatment.

- No evidence of bowel obstruction, malabsorption, or other contraindication to oral

- No serious non-healing wound, ulcer, or bone fracture.

- No major surgery, open biopsy or significant traumatic injury within 28 days of
registration for protocol therapy.

- No use of St. John's Wort or rifampin (rifampicin) while on protocol therapy.

- No condition that impairs patient's ability to swallow whole pills.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Phase I

Safety Issue:


Principal Investigator

Daniela Matei, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, Inc.


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

August 2010

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms



Arnett Cancer CareLafayette, Indiana  47904
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Medical Consultants, P.C.Muncie, Indiana  47303
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815
Schwartz Gynecologic Oncology, PLLCBabylon, New York  11702
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
St. Vincent Hospital Cynecologic OncologyIndianapolis, Indiana  46260