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VEGF Trap in Treating Patients With Recurrent or Persistent Endometrial Cancer
This study has been suspended.
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00462826
  Purpose

RATIONALE: VEGF Trap may stop the growth of endometrial cancer by blocking blood flow to the tumor and by carrying tumor-killing substances directly to endometrial cancer cells.

PURPOSE: This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with recurrent or persistent endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Drug: aflibercept
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Aflibercept
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation of VEGF-Trap (NSC #724770, IND #BB100137, NCI-Supplied Agent) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Designated as safety issue: No ]
  • Objective tumor response [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by CTCAE V.3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Designated as safety issue: No ]
  • Duration of overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: November 2007
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • 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
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462826

  Show 61 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Robert L. Coleman, MD M.D. Anderson Cancer Center
Investigator: Don S. Dizon, MD Women and Infants Hospital of Rhode Island
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000540237, GOG-0229F
Study First Received: April 18, 2007
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00462826  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma

Study placed in the following topic categories:
Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Endometrial cancer
Recurrence
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009