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VEGF Trap in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00462826
First received: April 18, 2007
Last updated: June 18, 2014
Last verified: June 2014
  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. 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.


Condition Intervention Phase
Recurrent Endometrial Carcinoma
Biological: ziv-aflibercept
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of VEGF-Trap (AFLIBERCEPT, NSC #724770, NCI-Supplied Agent) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 6 Month Progression-free Survival [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Number of participants who survived progression-free for more than 6 months.

  • Objective Tumor Response [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of Progression-free Survival [ Time Frame: From study entry until disease progression, death or date of last contact, up to 5 years ] [ Designated as safety issue: No ]
  • Duration of Overall Survival [ Time Frame: From entry into the study to death or the date of last contact, up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: November 2007
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (aflibercept)
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.
Biological: ziv-aflibercept
Other Names:
  • aflibercept
  • vascular endothelial growth factor trap
  • VEGF Trap
  • Zaltrap

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462826

  Show 67 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: Robert Coleman Gynecologic Oncology Group
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00462826     History of Changes
Other Study ID Numbers: NCI-2009-00597, NCI-2009-00597, CDR0000540237, GOG-0229F, GOG-0229F, U10CA027469
Study First Received: April 18, 2007
Results First Received: July 9, 2013
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms
Endothelial Growth Factors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014