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A Phase II Evaluation of VEGF-Trap (NSC #724770, IND #BB100137, NCI-Supplied Agent) in the Treatment of Recurrent or Persistent Endometrial Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Recurrent Endometrial Carcinoma

Thank you

Trial Information

A Phase II Evaluation of VEGF-Trap (NSC #724770, IND #BB100137, NCI-Supplied Agent) in the Treatment of Recurrent or Persistent Endometrial Carcinoma


PRIMARY OBJECTIVES:

I. Assess the activity of VEGF Trap in patients with recurrent or persistent endometrial
cancer, in terms of the frequency of patients who have progression-free survival for at
least 6 months after initiating therapy or have objective tumor response.

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

SECONDARY OBJECTIVES:

I. Determine the duration of progression-free survival and overall survival of patients
treated with this drug.

OUTLINE:

Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 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.


Inclusion Criteria:



- Histologically confirmed endometrial carcinoma, meeting both of the following
criteria:

- 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

- Tumors within a previously irradiated field are designated as nontarget lesions
unless progression is documented or a biopsy is obtained to confirm persistence
at least 90 days after completion of radiotherapy

- Must have received one prior chemotherapeutic regimen for management of endometrial
carcinoma (initial treatment may include high-dose therapy, consolidation therapy, or
extended therapy administered after surgical or non-surgical assessment)

- Not a candidate for a higher priority GOG protocol

- No history or evidence of primary brain tumor or brain metastases

- GOG performance status (PS) 0-2 (patients who received 1 prior regimen) OR GOG PS 0-1
(patients who received 2 prior regimens)

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Urine protein:creatinine ratio < 1.0 OR urine protein < 1.0 g by 24-hour urine
collection

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- PT/PTT/INR ≤ 1.5 times ULN

- In-range INR (between 2 and 3) allowed if patient is on a stable dose of
therapeutic warfarin

- QTc < 500 msec

- No evidence of serious ventricular arrhythmia

- Ventricular tachycardia or ventricular fibrillation must be < 3 beats in a row

- LVEF normal

- Ejection fraction ≥ 50% (for patients who received prior anthracycline,
including doxorubicin hydrochloride and/or doxorubicin hydrochloride liposome)

- No clinically significant cardiovascular disease, including any of the following:

- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 140 mm Hg
or diastolic BP > 90 mm Hg

- Myocardial infarction or unstable angina within the past 6 months

- NYHA class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Peripheral vascular disease ≥ grade 2

- Cerebrovascular accident (i.e., CVA or stroke), transient ischemic attack, or
subarachnoid hemorrhage within the past 6 months

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of study therapy

- No HIV positivity

- No neuropathy (sensory and motor) > grade 1

- No active infection requiring antibiotics

- No other invasive malignancies or any evidence of other cancer within the past 5
years except for nonmelanoma skin cancer

- No serious nonhealing wound, ulcer, or bone fracture

- No history of abdominal fistula or gastrointestinal perforation

- No history or evidence of seizures not controlled with standard medical therapy

- No intra-abdominal abscess within the past 28 days

- No active bleeding or pathologic conditions that carry a high risk of bleeding (e.g.,
bleeding disorder, coagulopathy, or tumor involving major vessels)

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human or humanized antibodies

- No significant traumatic injury within the past 28 days

- No concurrent combination antiretroviral therapy for HIV-positive patients

- Recovered from prior surgery

- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
or radiotherapy and recovered

- At least 1 week since prior hormonal therapy

- Concurrent hormone replacement therapy allowed

- At least 3 weeks since any other prior therapy, including immunologic agents

- One additional prior cytotoxic regimen for management of recurrent or persistent
endometrial cancer allowed

- Cytotoxic regimens include 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

- More than 28 days since prior major surgery or open biopsy

- More than 7 days since prior minor surgery, fine needle aspirates, or core biopsies

- No prior cancer treatment that would preclude study compliance

- No prior noncytotoxic chemotherapy for management of recurrent or persistent
endometrial disease

- No prior VEGF Trap or other VEGF pathway-targeted therapy

- More than 5 years since prior radiotherapy to any portion of the abdominal cavity or
pelvis except for the treatment of endometrial cancer

- More than 3 years since prior radiotherapy for localized cancer of the breast,
head and neck, or skin

- Patient must remain free of recurrent or metastatic disease

- More than 5 years since prior chemotherapy for any abdominal or pelvic tumor except
for the treatment of endometrial cancer

- More than 3 years since prior adjuvant chemotherapy for localized breast cancer

- Patient must remain free of recurrent or metastatic disease

- Concurrent low-molecular weight heparin allowed for the prevention or treatment of
venous thromboembolic disease if condition is considered clinically stable with
treatment

- No other concurrent investigational agents

- No concurrent major surgery

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

At 6 months

Safety Issue:

No

Principal Investigator

Robert Coleman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00597

NCT ID:

NCT00462826

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Recurrent Endometrial Carcinoma
  • Carcinoma
  • Adenoma
  • Endometrial Neoplasms

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Cleveland Clinic FoundationCleveland, Ohio  44195
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Washington University School of MedicineSaint Louis, Missouri  63110
Abington Memorial HospitalAbington, Pennsylvania  19001
University of Washington Medical CenterSeattle, Washington  98195-6043
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Gynecologic Oncology NetworkGreenville, North Carolina  27858
Hartford HospitalHartford, Connecticut  06102-5037
Franklin Square Hospital CenterBaltimore, Maryland  21237
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
MetroHealth Medical CenterCleveland, Ohio  44109
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Miami Valley HospitalDayton, Ohio  45409
Lawrence Memorial HospitalLawrence, Kansas  66044
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
North Kansas City HospitalKansas City, Missouri  64116
Research Medical CenterKansas City, Missouri  64132
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Washington Hospital CenterWashington, District of Columbia  20010
Fairview HospitalCleveland, Ohio  44111
Providence Medical CenterKansas City, Kansas  66112
Independence Regional Health CenterIndependence, Missouri  64050
Northwestern UniversityChicago, Illinois  60611
Case Western Reserve UniversityCleveland, Ohio  44106
Riverside Methodist HospitalColumbus, Ohio  43214
University of New MexicoAlbuquerque, New Mexico  87131
Florida HospitalOrlando, Florida  32803
Memorial Health University Medical CenterSavannah, Georgia  31404
Hillcrest Hospital Cancer CenterMayfield Heights, Ohio  44124
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
M D Anderson Cancer CenterHouston, Texas  77030
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
Saint Vincent Hospital and Health ServicesIndianapolis, Indiana  46260
Radiation Oncology Practice Corporation SouthwestOverland Park, Kansas  66210
Green Bay Oncology - EscanabaEscanaba, Michigan  49431
Green Bay Oncology - Iron MountainIron Mountain, Michigan  49801
Radiation Oncology Practice Corporation - NorthKansas City, Missouri  64154
Saint Luke's Cancer InstituteKansas City, Missouri  64111
Radiation Oncology Practice Corporation SouthKansas City, Missouri  64114
Saint Luke's Hospital of Kansas CityKansas City, Missouri  64111
Saint Joseph Health CenterKansas City, Missouri  64114
Liberty Radiation Oncology ClinicKansas City, Missouri  64116
Truman Medical CenterKansas City, Missouri  64108
Cooper Hospital University Medical CenterCamden, New Jersey  08103
Mount Carmel Health Center WestColumbus, Ohio  43222
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Green Bay Oncology - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology - Sturgeon BaySturgeon Bay, Wisconsin  54235
Cancer Care Associates-YaleTulsa, Oklahoma  74136-1929
Cancer Care Associates-MidtownTulsa, Oklahoma  74104
Women and Infants HospitalProvidence, Rhode Island  02905
Lake University Ireland Cancer CenterMentor, Ohio  44060
Jupiter Medical CenterJupiter, Florida  33458
University of IllinoisChicago, Illinois  60612
Stony Brook University Medical CenterStony Brook, New York  11794
Carilion Clinic Gynecological OncologyRoanoke, Virginia  24016
Northwest Medical Specialties PLLCTacoma, Washington  98405
Southwest Gynecologic Oncology Associates IncAlbuquerque, New Mexico  87106
Radiation Oncology Center of OlatheOlathe, Kansas  66061