Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Recurrent Uterine Sarcoma; Stage III Uterine Sarcoma; Stage IV Uterine Sarcoma; Uterine Carcinosarcoma	Drug: sorafenib tosylate	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	56 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma
Study Start Date :	February 2005
Actual Primary Completion Date :	July 2010
Actual Study Completion Date :	July 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Treatment; Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Drug: sorafenib tosylate; Given orally; Other Names: BAY 43-9006; BAY 43-9006 Tosylate Salt; BAY 54-9085; Nexavar; SFN

Outcome Measures

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Primary Outcome Measures :

1. Objective Overall Response Rate [ Time Frame: Up to 5 years ]
   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.

Secondary Outcome Measures :

1. Overall Survival [ Time Frame: Up to 5 years ]
   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.
2. Progression Free Survival [ Time Frame: Up to 5 years ]
   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.
3. Duration of Response [ Time Frame: Up to 5 years ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
University of Southern California
Los Angeles, California, United States, 90033-0804
United States, Illinois
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 60702
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Gini Fleming	University of Chicago Comprehensive Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00238121 History of Changes
Other Study ID Numbers:	NCI-2009-00068; 13572A; CDR0000445181; N01CM62203 ( U.S. NIH Grant/Contract )
First Posted:	October 13, 2005
Results First Posted:	June 10, 2014
Last Update Posted:	November 20, 2015
Last Verified:	January 2014

Additional relevant MeSH terms:

Sarcoma; Carcinosarcoma; Mixed Tumor, Mullerian; Uterine Neoplasms; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Complex and Mixed; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases	Genital Diseases, Female; Sorafenib; Niacinamide; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Vitamin B Complex; Vitamins; Micronutrients; Growth Substances; Physiological Effects of Drugs