Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

Uterine Carcinosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238121
• Other study ID #: NCI-2009-00068
• Secondary ID: 13572ACDR0000445
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2005
• Last updated: November 17, 2015
• Start date: February 2005
• Est. completion date: July 2010

Study information

• Verified date: January 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• sorafenib tosylate
Given orally

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario
Canada	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario
Canada	University Health Network-Princess Margaret Hospital	Toronto	Ontario
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	City of Hope Medical Center	Duarte	California
United States	University of Southern California	Los Angeles	California
United States	Central Illinois Hematology Oncology Center	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Overall Response Rate	Response was defined using the Response Evaluation Criteria in Solid Tumors (RECIST, http://www.ncbi.nlm.nih.gov/pubmed/10655437#): Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.	Up to 5 years	No
Secondary	Overall Survival	Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.	Up to 5 years	No
Secondary	Progression Free Survival	Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to RECIST, progressive disease(PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions.	Up to 5 years	No
Secondary	Duration of Response	Duration of response was measured from the time measurement criteria are met for CR(complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the RECIST: Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; progressive disease(PD), at least a 20% increase in the sum of the longest diameter of target lesions.	Up to 5 years	No