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Phase 2 N=34 Treatment

Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

Endometrial Adenocarcinoma · Endometrial Endometrioid Adenocarcinoma · Endometrial Serous Adenocarcinoma · Recurrent Uterine Corpus Carcinoma · Stage IVA Uterine Corpus Cancer AJCC v7

Enrolled (actual)
34
Serious AEs
90.9%
Results posted
Feb 2020
Primary outcome: Primary: Objective Response Rate — 6; 6; 16; 5 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Sunitinib Malate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
National Cancer Institute (NCI)
Primary completion
Feb 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response Rate
6; 6; 16; 5
SECONDARY
Number of Participants With Prolonged Stable Disease
SECONDARY
Overall Survival
19.4
SECONDARY
Number of Participants With Adverse Effects Assessed by CTCAE Version 3.0
30
SECONDARY
Time to Progression
3

Summary

This phase II trial studies how well sunitinib malate works in treating patients with endometrial cancer that has come back after a period of improvement (recurrent) or has spread to other places in the body (metastatic). 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.

Eligibility Criteria

Inclusion Criteria

  • Patients must have histologically or cytologically confirmed endometrial cancer; adenocarcinoma (endometrioid and serous/papillary serous) and carcinosarcoma (ie. malignant mixed Mullerian tumor [MMMT]) of the uterus will be investigated; patients with other histologies (eg. squamous cell carcinoma or leiomyosarcoma) are excluded
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; indicator lesions must not have been previously treated with surgery, radiotherapy, or radiofrequency ablation
  • Previously treated patients must have evidence of progressive disease, either clinically or radiographically, as assessed by the investigator
  • Eligible patients may have received no more than one prior cytotoxic chemotherapy regimen for recurrent, locally-advanced, or metastatic disease; if the prior chemotherapy was an anthracycline, they may have received no more than 6 cycles (or less than 450 mg/m^2 doxorubicin); patients must have completed any previous chemotherapy a minimum of 4 weeks (or 6 weeks if the regimen contained carmustine [BCNU] or mitomycin) prior to study registration; prior investigational treatment is permissible (as long as such treatment completed 4 weeks prior to registration)
  • Life expectancy of greater than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status = = 60)
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 100 g/dL
  • Serum calcium = = 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Serum lipase = = 0.5 mmol/L
  • Patients must have corrected QT interval (QTc) < 500 msec
  • The following group of patients are eligible provided they have normal baseline cardiac function (as determined by estimate of left ventricular ejection fraction [LVEF] on echocardiogram or multi-gated acquisition scan [MUGA]):
  • Those with a history of congestive heart failure, provided they are no greater than New York Heart Association (NYHA) class I and on treatment at baseline
  • Those with prior anthracycline exposure
  • Those who have received prior central thoracic radiation that included the heart in the radiotherapy port
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; all women of childbearing potential must have a negative pregnancy test prior to receiving sunitinib; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; at least 4 weeks must have elapsed since any major surgery
  • Patients may not be receiving any other investigational agents
  • Patients who have received prior treatment with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, vascular endothelial growth factor [VEGF] Trap, etc.) are ineligible
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib
  • Patients who have a history of serious ventricular arrhythmias (ventricular tachycardia [VT] or ventricular fibrillation [VF] equal to or greater than 3 beats in a row), QTc prolongation (defined as a QTc interval equal to or greater than 500 msec) or other significant electrocardiogram (ECG) abnormalities are excluded
  • Patients
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00478426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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