Clinical trial NCT00238121: Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer
Official title: A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Uterine Sarcoma
Stage III Uterine Sarcoma
Stage IV Uterine Sarcoma
Uterine Carcinosarcoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-10-13
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with advanced or recurrent uterine cancer.

Detailed description: PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

Eligibility criteria: 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 therapy
* 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

Primary outcomes:
measure: Objective Overall Response Rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 5 years
measure: Progression Free Survival
timeFrame: Up to 5 years
measure: Duration of Response
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Springfield
country: United States
facility: Central Illinois Hematology Oncology Center
state: Illinois
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre at Hamilton Health Sciences
state: Ontario
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network-Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: Gini Fleming
role: PRINCIPAL_INVESTIGATOR
References: