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Recurrent Uterine SarcomaPhase 2NCT00378911

Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

A Phase 2 study testing sunitinib malate in people with Recurrent Uterine Sarcoma and Uterine Leiomyosarcoma, run by National Cancer Institute (NCI) at 1 site in United States.

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

This phase II trial is studying how well sunitinib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus. Sunitinib 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
sunitinib malate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
Oct 2006to Jan 2010
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histologically confirmed leiomyosarcoma of the uterus
  • Recurrent or persistent disease
  • Refractory to curative therapy or established treatments
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Ascites and pleural effusions are not considered measurable disease
  • Must have ≥ 1 target lesion to assess response
Show all 97Show fewer
  • Tumors in a previously irradiated field are considered non-target lesions unless there is documented progression or biopsy-confirmed persistence ≥ 90 days after completion of radiotherapy
  • Received at least 1 but no more than 2 prior cytotoxic regimens
  • Initial treatment may have included high-dose chemotherapy, consolidation, or extended therapy administered after surgery or nonsurgical assessment
  • Cytotoxic regimens may have included any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
  • Not a candidate for a higher priority GOG protocol
  • No known brain metastases
  • GOG performance status 0-2 (for patients who have received 1 prior regimen) OR GOG 0-1 (for patients who have received 2 prior regimens)
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 1.5 times ULN
  • QTc < 500 msec
  • LVEF normal by echocardiogram
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
  • Patients with a pre-existing thyroid abnormality unable to maintain normal thyroid function with medication are not eligible
  • No significant EKG abnormalities (i.e., no history of serious ventricular arrhythmia OR EKG with ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • No sensory or motor neuropathy > grade 1
  • No NYHA class III-IV congestive heart failure
  • NYHA class II cardiac dysfunction allowed
  • History of NYHA class II heart failure that is asymptomatic on treatment allowed
  • No active infection requiring antibiotics
  • No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
  • No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
  • No gastrointestinal tract disease resulting in an inability to take oral medication
  • No requirement for IV alimentation
  • No active peptic ulcer disease
  • No other condition that would impair ability to swallow and retain study drug
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No cerebrovascular accident or transient ischemic attack within the past year
  • No myocardial infarction, cardiac arrhythmia, stable or unstable angina, or symptomatic congestive heart failure within the past year
  • No pulmonary embolism within the past year
  • No uncontrolled illness including, but not limited to, any of the following:
  • Ongoing or active infections
  • Psychiatric illness or social situations that would preclude study compliance
  • Recovered from prior surgery, chemotherapy, or radiotherapy
  • Prior anthracycline exposure and central thoracic radiation that included the heart allowed provided patient has New York Heart Association (NYHA) class II cardiac function
  • At least 1 week since prior hormonal therapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) or radiotherapy
  • At least 4 weeks since prior major surgery
  • At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and no recurrent or metastatic disease
  • At least 3 years since prior adjuvant chemotherapy for localized cancer of the breast and no recurrent or metastatic disease
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis unless for treatment of leiomyosarcoma
  • No prior chemotherapy to any portion of the abdominal cavity or pelvis unless for treatment of leiomyosarcoma
  • No prior noncytotoxic chemotherapy for recurrent or persistent disease
  • No prior surgical procedures affecting absorption
  • No coronary or peripheral artery bypass graft or stenting within the past year
  • No other prior antiangiogenic agents (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, vatalanib, or vascular endothelial growth factor [VEGF] Trap)
  • No other prior cancer treatment that would preclude study treatment
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
  • Azole fungals (e.g., ketoconazole or itraconazole)
  • Clarithromycin
  • Erythromycin
  • Diltiazem
  • Verapamil
  • HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir)
  • Delavirdine
  • At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
  • Rifampin
  • Rifabutin
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • Hypericum perforatum (St. John's wort)
  • Efavirenz
  • Tipranavir
  • No concurrent proarrhythmic potential agent, including any of the following:
  • Terfenadine
  • Quinidine
  • Procainamide
  • Disopyramide
  • Sotalol
  • Probucol
  • Bepridil
  • Haloperidol
  • Risperidone
  • Indapamide
  • Flecainide
  • No concurrent therapeutic coumarin-derivative anticoagulants, such as warfarin
  • Doses ≤ 2 mg daily allowed for prophylaxis of thrombosis
  • Low molecular weight heparin allowed provided PT INR ≤ 1.5
  • No concurrent amifostine or other protective agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Phase II Evaluation of Sunitinib Malate (Sutent®, SU11248, NCI-Supplied Agent , NSC # 736511) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus

This phase II trial is studying how well sunitinib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus. Sunitinib 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assess the activity of sunitinib malate, in terms of rate of progression-free survival for ≥ 6 months and objective tumor response, in patients with recurrent or persistent leiomyosarcoma of the uterus who have received 1 or 2 prior cytotoxic therapies.

II. Determine the frequency and severity of adverse events.

SECONDARY OBJECTIVES:

  1. Determine the duration of progression-free survival and overall survival.

OUTLINE: This is a multicenter study. Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Being tested
sunitinib malate

What participants receive

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

  • sunitinib malateDrug

    Also called SU11248, sunitinib, Sutent

    Given orally

Study groups in NCT00378911
Study groupRoleWhat they receive
Treatment (sunitinib malate)ExperimentalPatients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: sunitinib malate

What is being measured

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

  1. Progression-free survival

    Measured: From study entry until disease progression, death or date of last contact., assessed up to 6 months

  2. Objective tumor response according to GOG RECIST criteria

    Measured: Up to 5 years

  3. Frequency and severity of adverse events as assessed by CTCAE v 3.0

    The frequency and severity of all toxicities will be tabulated.

    Measured: Up to 5 years

Secondary outcomes (2)

  1. Duration of progression-free survival

    Characterized graphically and using descriptive statistics such as median survival.

    Measured: Up to 5 years

  2. Duration of overall survival

    Characterized graphically and using descriptive statistics such as median survival.

    Measured: From entry into the study to death or the date of last contact, assessed 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 posted21 Sep 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJun 2007
  4. Study completionJan 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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00378911
Sponsor's protocol ID
NCI-2012-02702
Other IDs
NCI-2012-02702, CDR0000495190, GOG-0231C, GOG-0231C, U10CA027469
Status last verified
Jul 2019
First submitted
19 Sep 2006
Last updated
23 Jul 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib malate in people with Recurrent Uterine Sarcoma and Uterine Leiomyosarcoma, run by National Cancer Institute (NCI) at 1 site in United States.

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 97 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-free survival (time frame: From study entry until disease progression, death or date of last contact., assessed up to 6 months). The study lists 3 primary outcomes in all. 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 NCT00378911.

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 23 Jul 2019.

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