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A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma

Phase 2
18 Years
Open (Enrolling)
Recurrent Uterine Sarcoma, Stage III Uterine Sarcoma, Stage IV Uterine Sarcoma, Uterine Carcinosarcoma

Thank you

Trial Information

A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma


I. Determine the objective response rate in patients with advanced or recurrent uterine
cancer treated with sorafenib.

II. Determine the toxic effects of this drug in these patients.


I. Determine progression-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to histology
(carcinoma vs carcinosarcoma).

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

Inclusion Criteria:

- No prior sorafenib

- Histologically or cytologically confirmed uterine carcinoma or carcinosarcoma:

- Advanced or recurrent disease

- Not amenable to curative surgery or radiotherapy

- Measurable disease:

- At least 1 unidimensionally measurable lesion >= 20 mm by conventional
techniques OR >= 10 mm by spiral CT scan

- Tumor tissue block must be available

- No known brain metastases

- Performance status:

- ECOG 0-2 OR

- Karnofsky 60-100%

- Hematopoietic:

- Absolute neutrophil count >= 1,500/mm3

- Platelet count >= 100,000/mm3

- No bleeding diathesis

- Hepatic:

- Bilirubin normal

- AST and ALT =< 2.5 times upper limit of normal

- Renal:

- Creatinine =< 1.5 mg/dL OR

- Creatinine clearance >= 60 mL/min

- Cardiovascular:

- No uncontrolled hypertension, defined by 1 of the following:

- Blood pressure > 150/100 mm Hg

- Currently taking > 1 antihypertensive agent

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other active malignancy

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to sorafenib

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No swallowing dysfunction that would preclude study drug ingestion

- No other uncontrolled illness

- Prior biological response modifier therapy allowed

- No prior antiangiogenesis therapy

- No prior MAPK-signaling agents

- No prior vascular endothelial growth factor receptor (VEGFR) inhibitors

- No more than 1 prior chemotherapy regimen

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

- Prior hormonal therapy allowed

- Prior radiotherapy allowed provided the only site of measurable disease was not
located within the radiation port OR disease has progressed since completion of

- Recovered from all prior therapy

- Concurrent warfarin allowed provided all of the following are true:

- Patient is therapeutic on a stable warfarin dose

- INR target range =< 3

- Patient is monitored with weekly INR testing

- No active bleeding or pathological condition that carries a high bleeding risk

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin,
carbamazepine, or phenobarbital)

- No concurrent rifampin

- No concurrent Hypericum perforatum (St. John's wort)

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- More than 4 weeks since prior radiotherapy

Type of Study:


Study Design:

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

Outcome Measure:

Tumor response rate (complete or partial), as measured by RECIST criteria

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Gini Fleming

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

  • Recurrent Uterine Sarcoma
  • Stage III Uterine Sarcoma
  • Stage IV Uterine Sarcoma
  • Uterine Carcinosarcoma
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Uterine Neoplasms
  • Sarcoma



Central Illinois Hematology Oncology Center Springfield, Illinois  62701
City of Hope Medical Center Duarte, California  91010
Decatur Memorial Hospital Decatur, Illinois  62526
University of Southern California Los Angeles, California  90033