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A Phase II Study of Sunitinib Malate in Recurrent or Metastatic Endometrial Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Endometrial Adenocarcinoma, Endometrial Papillary Serous Carcinoma, Recurrent Endometrial Carcinoma, Recurrent Uterine Sarcoma, Stage IV Endometrial Carcinoma, Stage IV Uterine Sarcoma, Uterine Carcinosarcoma

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Trial Information

A Phase II Study of Sunitinib Malate in Recurrent or Metastatic Endometrial Carcinoma


PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with recurrent or metastatic
endometrial cancer treated with sunitinib malate.

II. Determine the frequency of prolonged stable disease (as defined by percentage of
patients alive and free from progressive disease at 6 months) in patients treated with this
drug.

SECONDARY OBJECTIVES:

I. Determine time to progression, median overall survival, and rate of one-year survival in
patients treated with this drug.

II. Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6
weeks in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed at 4 weeks.

Inclusion Criteria


Criteria:

- At least 4 weeks since prior and no other concurrent investigational treatment

- At least 7 days since prior and no concurrent CYP3A4 inhibitors

- At least 12 days since prior and no concurrent CYP3A4 inducers

- No prior antiangiogenic agents (e.g., bevacizumab, sorafenib, pazopanib, AZD2171,
vatalanib, VEGF Trap)

- No concurrent coumadin-derivative anticoagulants (e.g., warfarin) Thrombosis
prophylaxis therapy (2 mg daily) allowed Low molecular weight heparin allowed
provided PT/INR is =< 1.5

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent anticancer agents or therapies

- No concurrent agents with proarrhythmic potential including, but not limited to, the
following

- Histologically or cytologically confirmed endometrial cancer [Adenocarcinoma (e.g.,
endometrioid, serous, or papillary serous) or carcinosarcoma (e.g., malignant mixed
mullerian tumor of the uterus), no other histologies (e.g., squamous cell carcinoma
or leiomyosarcoma)]

- Patients meeting any of the following criteria are eligible provided they have normal
LVEF on ECHO or MUGA scan:

- History of congestive heart failure with NYHA =< class I and on treatment

- Prior anthracycline exposure

- Received prior central thoracic radiation that included the heart in the
radiotherapy port

- Patients with previously treated disease must have clinical or radiographic evidence
of progressive disease

- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm with
conventional techniques or >= 10 mm with spiral CT scan (No indicator lesions
previously treated with surgery, radiotherapy, or radiofrequency ablation)

- No known brain metastases

- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

- Life expectancy > 3 months

- WBC >= 3,000/mm^3

- ANC >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Hemoglobin >= 100 mg/dL

- Calcium =< 12.0 mg/dL

- Bilirubin normal

- AST and ALT =< 2.5 times upper limit of normal

- Creatinine normal OR creatinine clearance >= 60 mL/min

- Serum lipase or serum amylase =< 1.5 times upper limit of normal

- Magnesium >= 0.5 mmol/L

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- QTc < 500 msec

- No significant ECG abnormalities

- No serious or non-healing wound, ulcer, or bone fracture

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 28 days

- No pulmonary embolism within the past 12 months

- No NYHA class III or IV heart failure

- No pre-existing adrenal insufficiency (primary or secondary)

- No condition that impairs the ability to swallow and retain sunitinib malate tablets
(e.g., gastrointestinal tract disease resulting in an inability to take oral
medication; requirement for IV alimentation; prior surgical procedures affecting
absorption; or active peptic ulcer disease)

- No history of allergic reactions to compounds of similar chemical or biological
composition to sunitinib malate

- No pre-existing thyroid abnormality unable to maintain normal range thyroid function
with medication

- No concurrent uncontrolled illness including, but not limited to, ongoing or active
infection, psychiatric illness, or social situation that would preclude study
compliance

- No uncontrolled hypertension (i.e., systolic blood pressure [BP] >= 140 mm Hg or
diastolic BP >= 90 mm Hg)

- More than 4 weeks since prior chemotherapy (6 weeks for carmustine, nitrosoureas or
mitomycin C) and recovered

- No more than 6 prior courses of anthracycline chemotherapy (or < 450 mg/m^2 of
doxorubicin hydrochloride)

- No more than 1 prior cytotoxic chemotherapy regimen for recurrent, locally advanced,
or metastatic disease

- More than 4 weeks since prior radiotherapy and recovered

- At least 4 weeks since prior major surgery

- TSH, T3, or T4 normal

- No cerebrovascular accident or transient ischemic attack within the past 12 months

- No myocardial infarction, cardiac arrhythmia, stable or unstable angina, symptomatic
congestive heart failure, or coronary/peripheral artery bypass graft or stenting
within the past 12 months

- Histologically or cytologically confirmed endometrial cancer

- Adenocarcinoma (e.g., endometrioid, serous, or papillary serous) or carcinosarcoma
(e.g., malignant mixed müllerian tumor of the uterus)

- No other histologies (e.g., squamous cell carcinoma or leiomyosarcoma)

- Patients with previously treated disease must have clinical or radiographic evidence
of progressive disease

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with
conventional techniques or ≥ 10 mm with spiral CT scan

- No indicator lesions previously treated with surgery, radiotherapy, or radiofrequency
ablation

- No known brain metastases

- Patients meeting any of the following criteria are eligible provided they have normal
LVEF on ECHO or MUGA scan:

- History of congestive heart failure with NYHA ≤ class I and on treatment

- Prior anthracycline exposure

- Received prior central thoracic radiation that included the heart in the radiotherapy
port

- At least 4 weeks since prior and no other concurrent investigational treatment

- At least 7 days since prior and no concurrent CYP3A4 inhibitors, including the
following:

- Azole antifungals (ketoconazole, itraconazole)

- Clarithromycin

- Erythromycin

- Diltiazem

- Verapamil

- HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir,
nelfinavir)

- Delavirdine

- At least 12 days since prior and no concurrent CYP3A4 inducers, including the
following:

- Rifampin

- Rifabutin

- Carbamazepine

- Phenobarbital

- Phenytoin

- Hypericum perforatum (St. John's wort)

- Efavirenz

- Tipranavir

- No prior antiangiogenic agents (e.g., bevacizumab, sorafenib, pazopanib,
AZD2171, vatalanib, VEGF Trap)

- No concurrent coumadin-derivative anticoagulants (e.g., warfarin)

- Thrombosis prophylaxis therapy (2 mg daily) allowed

- Low molecular weight heparin allowed provided PT/INR is ≤ 1.5

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent anticancer agents or therapies

- No concurrent agents with proarrhythmic potential including, but not limited to, the
following:

- Terfenadine

- Quinidine

- Procainamide

- Disopyramide

- Sotalol

- Probucol

- Bepridil

- Haloperidol

- Risperidone

- Indapamide

- Flecainide

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (complete or partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

Amit Oza

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network-Princess Margaret Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00210

NCT ID:

NCT00478426

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Endometrial Adenocarcinoma
  • Endometrial Papillary Serous Carcinoma
  • Recurrent Endometrial Carcinoma
  • Recurrent Uterine Sarcoma
  • Stage IV Endometrial Carcinoma
  • Stage IV Uterine Sarcoma
  • Uterine Carcinosarcoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Cystadenocarcinoma, Serous
  • Adenoma
  • Uterine Neoplasms
  • Endometrial Neoplasms
  • Sarcoma

Name

Location

City of HopeDuarte, California  91010
Decatur Memorial HospitalDecatur, Illinois  62526
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470