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CompletedNCT00238121Updated Nov 20, 2015Results posted

Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

A Phase 2 interventional study of sorafenib tosylate in Recurrent Uterine Sarcoma, Stage III Uterine Sarcoma and Stage IV Uterine Sarcoma, sponsored by National Cancer Institute (NCI). Completed at 7 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-20.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Recurrent Uterine Sarcoma
  • Stage III Uterine Sarcoma
  • Stage IV Uterine Sarcoma
  • Uterine Carcinosarcoma
03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 56 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • 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

Interventions

  • Drugsorafenib tosylate

    Given orally

    Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 5 years

Secondary outcomes

  1. 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.

    Time frame: Up to 5 years

  2. 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.

    Time frame: Up to 5 years

  3. 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.

    Time frame: Up to 5 years

07

Results

Posted Jun 10, 2014

Participant flow

The study population consisted of patients at least 18 years old with advanced or recurrent carcinoma, or uterine carcinosarcoma. Both cohorts received a starting dose of 400 mg sorafenib orally twice daily on a continuous basis.

Participant flow — Overall Study
MilestoneCarcinomaCarcinosarcoma
Started4016
Completed3714
Not completed32
Withdrew: Withdrawal by subject11
Withdrew: Adverse event21

Outcome measures

PrimaryObjective 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.

Time frame:
Up to 5 years
Reported as:
Number · participants
Objective Overall Response Rate
participantsCarcinomaCarcinosarcoma
Objective Overall Response Rate20
SecondaryOverall 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.

Time frame:
Up to 5 years
Reported as:
Median · Month
Overall Survival
MonthCarcinomaCarcinosarcoma
Overall Survival11.4 (6.9 to 17.7)5 (1.4 to 14)
SecondaryProgression 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.

Time frame:
Up to 5 years
Reported as:
Median · Month
Progression Free Survival
MonthCarcinomaCarcinosarcoma
Progression Free Survival3.2 (1.9 to 4)1.8 (1.4 to 3.5)
SecondaryDuration 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.

Time frame:
Up to 5 years
Reported as:
Mean · Month
Duration of Response
MonthCarcinomaCarcinosarcoma
Duration of Response25 (10 to 40)—

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sorafenib—11/56 (19.6%)56/56 (100%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventSorafenib
Death not associated with CTCAE term : Disease progression NOSGeneral disorders2/56
Infection with unknown ANC : Lung (pneumonia)Infections and infestations2/56
Thrombosis/embolism (vascular access-related)Injury, poisoning and procedural complications2/56
Colitis, infectious (e.g., Clostridium difficile)Infections and infestations1/56
DehydrationMetabolism and nutrition disorders1/56
Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders1/56
Fatigue (asthenia, lethargy, malaise)General disorders1/56
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infeBlood and lymphatic system disorders1/56
Fistula, GI : Colon/cecum/appendixGastrointestinal disorders1/56
Fistula, GU : VaginaReproductive system and breast disorders1/56
Most frequent other events
Showing 10 of 62
Most frequent other events
EventSorafenib
Fatigue (asthenia, lethargy, malaise)General disorders27/56
Rash/desquamationSkin and subcutaneous tissue disorders26/56
AnorexiaMetabolism and nutrition disorders25/56
DiarrheaGastrointestinal disorders24/56
Pain : Abdomen NOSGastrointestinal disorders24/56
HemoglobinBlood and lymphatic system disorders21/56
NauseaGastrointestinal disorders20/56
Rash: hand-foot skin reactionSkin and subcutaneous tissue disorders20/56
AST, SGOT(serum glutamic oxaloacetic transaminase)Investigations18/56
HypertensionVascular disorders18/56

Baseline characteristics

Age, Customized
Age, Customized(years)CarcinomaCarcinosarcomaTotal
Median64 (44 to 83)64 (40 to 87)64 (40 to 87)
Sex: Female, Male
Sex: Female, Male(Participants)CarcinomaCarcinosarcomaTotal
Female401656
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)CarcinomaCarcinosarcomaTotal
Non-Hispanic white291039
Hispanic415
African-American235
Asian527
Histology
Histology(participants)CarcinomaCarcinosarcomaTotal
Adenocarcinoma (unspecified)12012
Serous303
Clear cell101
Endometrioid24024
Carcinosarcoma01616
08

Study locations

7 sites
  • City of Hope Medical Center
    Duarte, California 91010, United States
  • University of Southern California
    Los Angeles, California 90033-0804, United States
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
  • Central Illinois Hematology Oncology Center
    Springfield, Illinois 60702, United States
  • Juravinski Cancer Centre at Hamilton Health Sciences
    Hamilton, Ontario L8V 5C2, Canada
  • Cancer Centre of Southeastern Ontario at Kingston General Hospital
    Kingston, Ontario K7L 5P9, Canada
  • University Health Network-Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00238121
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 13, 2005
Start date
Feb 2005
Primary completion
Jul 2010
Completion
Jul 2010
Results posted
Jun 10, 2014
Last update
Nov 20, 2015

Study contacts

Gini Fleming
principal investigator · University of Chicago Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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