Fallopian Tube Cancer Clinical Trial
Official title:
A Phase II Study of VEGF-Trap in Recurrent or Metastatic Gynecologic Soft-Tissue Sarcomas
Verified date | May 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This phase II trial is studying how well ziv-aflibercept works in treating patients with locally advanced, unresectable or metastatic gynecologic soft tissue sarcoma. Ziv-aflibercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Status | Completed |
Enrollment | 63 |
Est. completion date | August 2013 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically/cytologically confirmed soft tissue sarcoma of gynecologic tract including 1 of the following subtypes: uterine leiomyosarcoma, malignant mixed mullerian tumor/carcinosarcoma, disease originating in ovary/fallopian tube allowed - Locally advanced/unresectable/metastatic disease - Previously treated disease must have radiographic/clinical evidence of PD - Measurable disease-at least 1 lesion in at least 1 dimension (longest diameter) as >=20mm with conventional techniques or as >=10mm with spiral CT scan - Indicator lesions may not have been previously treated with surgery/radiotherapy/radiofrequency ablation unless PD has been confirmed - ECOG PS 0-2 OR Karnofsky PS 60-100% - Life expectancy>=3 months - WBC>=3,000/mm^3 - Absolute neutrophil count>=1,500/mm^3 - Platelet count>=75,000/mm^3 - Bilirubin=<1.5xULN - AST and ALT=<3xULN - INR=<1.5 (unless on warfarin) - Creatinine=<1.5xULN OR creatinine clearance>=60 mL/min - Urine protein<1+ by dipstick OR 24-hour urine protein<500 mg OR urine protein:creatinine ratio<1 - Not pregnant/nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for =6 months after treatment - No other active malignancy within past 5 years except adequately treated cervical carcinoma in situ/nonmelanoma skin cancer - No known hypersensitivity to Chinese hamster ovary cell products/other recombinant human antibodies - No history of allergic reactions attributed to compounds of similar chemical/biological composition to study agents - No serious/nonhealing wound/ulcer/bone fracture - No abdominal fistula/gastrointestinal perforation/bowel obstruction/intraabdominal abscess within past 28 days - No significant traumatic injuries within past 28 days - No evidence of bleeding diathesis/coagulopathy - No uncontrolled intercurrent illness including but not limited to: Ongoing/active infection, psychiatric illness or social situations that would preclude study compliance - <=2 prior cytotoxic chemotherapy regimen for recurrent, locally advanced or metastatic disease - Recovered from prior therapy - No prior antiangiogenic agent Exclusion Criteria: - < 4weeks since prior chemotherapy (<6 weeks for nitrosoureas/carmustine/mitomycin C), prior investigational treatment, radiotherapy and major surgery/open biopsy - 1 week since prior core biopsy - 1 month since prior thrombolytic agents - Concurrent full-dose anticoagulants with INR>1.5 allowed if: In-range INR (usually between 2-3) on stable dose of oral anticoagulant or low molecular weight heparin, - OR; For patients on warfarin, the upper target for INR is =3 No active bleeding/pathological condition that carries a high risk of bleeding (e.g. tumor invading major vessels/known varices) - No evidence of CNS disease including primary brain tumor/brain metastasis - No other concurrent investigational agents - No concurrent major surgery - No concurrent combination antiretroviral therapy for HIV-positive patients - Clinically significant cardiovascular disease including: - Cerebrovascular accident within past 6 months, - Uncontrolled hypertension defined as BP>150/100mmHg OR systolic BP>180mmHg if diastolic BP<90 mmHg, on =2 repeated determinations on separate days within past 3 months, - OR; Antihypertensive medications allowed as long as dose and number of antihypertensive medications have not increased within past 2 weeks, Myocardial infarction, coronary artery bypass graft, or unstable angina within past 6 months, OR; - OR; NYHA class III-IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris within past 6 months, Clinically significant peripheral vascular disease within past 6 months - OR; pulmonary embolism, deep vein thrombosis, or other thromboembolic event within past 6 months |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario |
Canada | London Regional Cancer Program | London | Ontario |
Canada | McGill University Department of Oncology | Montreal | Quebec |
Canada | Odette Cancer Centre- Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | University Health Network-Princess Margaret Hospital | Toronto | Ontario |
Canada | BCCA-Vancouver Cancer Centre | Vancouver | British Columbia |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
United States | University of Michigan University Hospital | Ann Arbor | Michigan |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | City of Hope | Duarte | California |
United States | Evanston CCOP-NorthShore University HealthSystem | Evanston | Illinois |
United States | University of Southern California | Los Angeles | California |
United States | Peoria Gynecologic Oncology | Peoria | Illinois |
United States | Fox Chase Cancer Center | Rockledge | Pennsylvania |
United States | UC Davis Comprehensive Cancer Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate, Evaluated According to the RECIST Criteria | Up to 3 years | No | |
Primary | Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group) | 6 months | No | |
Primary | Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group) | 6 months | No | |
Secondary | Survival (Leiomyosarcoma Group) | Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible. | Up to 3 years | No |
Secondary | Survival (Carcinosarcoma Group) | Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible. | Up to 3 years | No |
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