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Fallopian Tube CancerPhase 2NCT00390234

Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma

A Phase 2 study testing ziv-aflibercept in people with Fallopian Tube Cancer and Female Reproductive Cancer, run by National Cancer Institute (NCI) at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
ziv-aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
16 sitesin 2 countries
Study dates
Sep 2006to Aug 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
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  • 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

Who cannot join

  • < 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
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  • 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

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

United States8 sites

  • University of Michigan University Hospital

    Ann Arbor, Michigan, 48109

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

  • City of Hope

    Duarte, California, 91010

  • Evanston CCOP-NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • University of Southern California

    Los Angeles, California, 90033-0804

  • Peoria Gynecologic Oncology

    Peoria, Illinois, 61603

  • Fox Chase Cancer Center

    Rockledge, Pennsylvania, 19046

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

Other trials in United States

Canada8 sites

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5C 1M9

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Phase II Study of VEGF-Trap in Recurrent or Metastatic Gynecologic Soft-Tissue Sarcomas

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the objective response of recurrent or metastatic gynecologic soft-tissue sarcomas to VEGF-Trap (ziv-aflibercept).

II. To assess the incidence of disease stabilization, as measured by 6-month progression-free survival, in patients with recurrent or metastatic gynecologic soft-tissue sarcomas treated with VEGF-Trap.

SECONDARY OBJECTIVES:

  1. To assess time-to-progression and overall survival in patients with recurrent or metastatic gynecologic soft-tissue sarcoma treated with VEGF-Trap.
  • As of 24 October 2012, overall survival follow-up is to be discontinued for the one remaining patient on long term follow-up, who has been off protocol therapy for at least 3 years. Time to progression and median survival times have been based on the currently available data.

II. To assess the toxicity associated with VEGF-Trap in patients with recurrent or metastatic gynecologic soft-tissue sarcoma.

III. To characterize the population pharmacokinetics of VEGF-Trap and to explore for demographic and clinical covariates

OUTLINE: This is an open-label, multicenter study.

Patients are stratified according to histology (uterine leiomyosarcoma vs malignant mixed mullerian tumor/carcinosarcoma). Patients receive ziv-aflibercept over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection at baseline, every 8 weeks during treatment, and 60 days after completion of study treatment for population pharmacokinetic analysis using enzyme-linked immunosorbent assay (ELISA).

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Being tested
ziv-aflibercept
Medical subject headings
Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ziv-afliberceptDrug

    Also called aflibercept, vascular endothelial growth factor trap, VEGF Trap, Zaltrap

    Given IV

Study groups in NCT00390234
Study groupRoleWhat they receive
Treatment (ziv-aflibercept)ExperimentalPatients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: ziv-aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate, Evaluated According to the RECIST Criteria

    Measured: Up to 3 years

  2. Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)

    Measured: 6 months

  3. Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)

    Measured: 6 months

Secondary outcomes (2)

  1. 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.

    Measured: Up to 3 years

  2. 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.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionSep 2011
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00390234
Sponsor's protocol ID
NCI-2009-00177
Other IDs
PHL-051, CDR0000508798, N01CM62209, N01CM62203, N01CM62201
Status last verified
May 2013
First submitted
18 Oct 2006
Last updated
7 Dec 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ziv-aflibercept in people with Fallopian Tube Cancer and Female Reproductive Cancer, run by National Cancer Institute (NCI) at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate, Evaluated According to the RECIST Criteria (time frame: Up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00390234.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.

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