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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00462826 |
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 |
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Endometrial Cancer |
Drug: aflibercept |
Phase II |
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 |
Estimated Enrollment: | 43 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial carcinoma, meeting both of the following criteria:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
PATIENT CHARACTERISTICS:
PT/PTT/INR ≤ 1.5 times ULN
No evidence of serious ventricular arrhythmia
LVEF normal
No clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 1 week since prior hormonal therapy
One additional prior cytotoxic regimen for management of recurrent or persistent endometrial cancer allowed
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
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
Study Chair: | Robert L. Coleman, MD | M.D. Anderson Cancer Center |
Investigator: | Don S. Dizon, MD | Women and Infants Hospital of Rhode Island |
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 |
recurrent endometrial carcinoma |
Genital Diseases, Female Endometrial Neoplasms Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms |
Urogenital Neoplasms Endometrial cancer Recurrence Carcinoma |
Neoplasms Neoplasms by Site |