- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378911
Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Gynecologic Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (sunitinib malate)
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.
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Given orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: From study entry until disease progression, death or date of last contact., assessed up to 6 months
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From study entry until disease progression, death or date of last contact., assessed up to 6 months
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Objective tumor response according to GOG RECIST criteria
Time Frame: Up to 5 years
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Up to 5 years
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Frequency and severity of adverse events as assessed by CTCAE v 3.0
Time Frame: Up to 5 years
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The frequency and severity of all toxicities will be tabulated.
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Up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of progression-free survival
Time Frame: Up to 5 years
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Characterized graphically and using descriptive statistics such as median survival.
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Up to 5 years
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Duration of overall survival
Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years
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Characterized graphically and using descriptive statistics such as median survival.
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From entry into the study to death or the date of last contact, assessed up to 5 years
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Disease Attributes
- Sarcoma
- Neoplasms, Muscle Tissue
- Recurrence
- Leiomyosarcoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- NCI-2012-02702 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA027469 (U.S. NIH Grant/Contract)
- CDR0000495190
- GOG-0231C (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Uterine Sarcoma
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National Cancer Institute (NCI)NRG OncologyTerminatedRecurrent Uterine Corpus Sarcoma | Uterine Corpus Leiomyosarcoma | Stage IIIA Uterine Sarcoma | Stage IIIB Uterine Sarcoma | Stage IIIC Uterine Sarcoma | Stage IVA Uterine Sarcoma | Stage IVB Uterine SarcomaUnited States
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National Cancer Institute (NCI)CompletedUterine Carcinosarcoma | Recurrent Uterine Sarcoma | Stage III Uterine Sarcoma | Stage IV Uterine SarcomaUnited States, Canada
-
National Cancer Institute (NCI)NRG OncologyCompletedRecurrent Uterine Corpus Sarcoma | Uterine Corpus LeiomyosarcomaUnited States
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Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedBone Cancer | Chondrosarcoma | Recurrent Osteosarcoma | Clear Cell Sarcoma of the Kidney | Metastatic Osteosarcoma | Ovarian Sarcoma | Recurrent Adult Soft Tissue Sarcoma | Recurrent Uterine Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage III Uterine Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage...United States
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National Cancer Institute (NCI)NRG OncologyCompletedRecurrent Uterine Corpus Sarcoma | Uterine Corpus LeiomyosarcomaUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Uterine Corpus Sarcoma | Recurrent Uterine Corpus Carcinoma | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus Cancer | Recurrent Cervical Carcinoma | Stage III Uterine Sarcoma | Stage IV Uterine Sarcoma | Stage I Uterine... and other conditionsUnited States
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National Cancer Institute (NCI)Gynecologic Oncology GroupCompletedRecurrent Uterine Corpus Sarcoma | Uterine CarcinosarcomaUnited States
-
National Cancer Institute (NCI)Gynecologic Oncology GroupCompletedRecurrent Uterine Corpus Sarcoma | Uterine Corpus LeiomyosarcomaUnited States
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National Cancer Institute (NCI)TerminatedUterine Carcinosarcoma | Recurrent Uterine SarcomaUnited States
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National Cancer Institute (NCI)Gynecologic Oncology GroupCompletedUterine Carcinosarcoma | Recurrent Uterine SarcomaUnited States
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