NCT00238121 · REGISTRY CONDITION SEARCH

Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2015-11-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Overall Response Rate

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression Free Survival

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outcome · POSTED

Duration of Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
intervention Names
Drug: sorafenib tosylate
label
Treatment
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment
description
Given orally
name
sorafenib tosylate
other Names
BAY 43-9006
BAY 43-9006 Tosylate Salt
BAY 54-9085
Nexavar
SFN
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 56
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Objective Overall Response Rate
time Frame
Up to 5 years

secondary Outcomes

description
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.
measure
Overall Survival
time Frame
Up to 5 years
description
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.
measure
Progression Free Survival
time Frame
Up to 5 years
description
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.
measure
Duration of Response
time Frame
Up to 5 years

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-2dbe011c42ccecad09b3
requested nct id
NCT00238121
primary nct id
NCT00238121
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
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source file sha256
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payload sha256
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payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-2dbe011c42ccecad09b3
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00238121
occurrences
context exact
NCT00238121
end
11
exact text
NCT00238121
start
0
offset unit
unicode_code_points
query cond
Uterine Sarcoma
query disease state id
ds-uterine-sarcoma
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
source file sha256
21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
source json pointer
/studies/21/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
44ca5dade16f3b70194634a52ede4b812040cc73861023c7b09531c3b88bcd5f
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice