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Recurrent Uterine SarcomaPhase 2NCT00238121

Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

A Phase 2 study testing sorafenib tosylate in people with Recurrent Uterine Sarcoma and Stage III Uterine Sarcoma, run by National Cancer Institute (NCI) at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
sorafenib tosylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
7 sitesin 2 countries
Study dates
Feb 2005to Jul 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 55Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States4 sites

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • City of Hope Medical Center

    Duarte, California, 91010

  • University of Southern California

    Los Angeles, California, 90033-0804

  • Central Illinois Hematology Oncology Center

    Springfield, Illinois, 60702

Other trials in United States

Canada3 sites

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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:

  1. 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:

  1. 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.

Being tested
sorafenib tosylate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sorafenib tosylateDrug

    Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar

    Given orally

Study groups in NCT00238121
Study groupRoleWhat they receive
TreatmentExperimentalPatients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: sorafenib tosylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00238121
Sponsor's protocol ID
NCI-2009-00068
Other IDs
13572A, CDR0000445181, N01CM62203
Status last verified
Jan 2014
First submitted
12 Oct 2005
Last updated
20 Nov 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib tosylate in people with Recurrent Uterine Sarcoma and Stage III Uterine Sarcoma, run by National Cancer Institute (NCI) at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 55 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Overall Response Rate (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00238121.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.

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