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Malignant Ovarian Epithelial TumorPhase 2NCT00748657

Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary

A Phase 2 study testing Bevacizumab and Laboratory Biomarker Analysis in people with Malignant Ovarian Epithelial Tumor and Ovarian Granulosa Cell Tumor, run by National Cancer Institute (NCI) at 36 sites in United States.

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 studies how well bevacizumab works in treating patients with sex cord-stromal tumors of the ovary that have come back. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bevacizumab and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
36 sitesUnited States
Study dates
22 Sep 2008to 31 Jan 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

  • Patients diagnosed with histologically confirmed recurrent ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor [androblastoma], steroid [lipid] cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules)
  • Patients must have measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
  • Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each ?target? lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT
  • Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
  • Patients of childbearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control
  • Patients who have met the pre-entry requirements specified
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  • There are no restrictions on prior therapy; however, patients cannot have previously had treatment with bevacizumab
  • Absolute neutrophil count (ANC) >= 1,000/?l
  • Platelets greater than or equal to 75,000/?l
  • Creatinine =< 1.5 x institutional upper limit normal (ULN)
  • Bilirubin =< 1.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) less 2.5 x ULN
  • Alkaline phosphatase less 2.5 x ULN
  • Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) version (v)3.0 grade 1
  • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.2 times the upper limit of normal
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information

Who cannot join

  • Patients with newly diagnosed disease
  • Patients with serious non-healing wound, ulcer, or bone fracture
  • Patients who have received prior therapy with bevacizumab or other inhibitors of vascular endothelial growth factor (VEGF)
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within 6 months of the first date of treatment on this study
  • Patients with clinically significant cardiovascular disease; this includes:
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  • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg
  • Myocardial infarction or unstable angina within 6 months prior to registration
  • New York Heart Association (NYHA) grade II or greater congestive heart failure
  • Serious cardiac arrhythmic requiring medication.
  • Grade 2 or greater peripheral vascular disease
  • Patients with GOG performance grade of 3 or 4
  • Patients with clinically significant peripheral arterial disease; e.g., claudication within 6 months
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically; a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24 hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR < 1.0 to allow participation in the study
  • Patients with a history of cardiovascular accident (CVA) within 6 months prior to registration
  • Patients with any signs of bowel obstruction or patients who require parenteral hydration and/or nutrition
  • Patients whose circumstances do not permit completion of the study or the required follow-up
  • Patients who are pregnant or nursing; patients who may become pregnant must agree to use contraceptive measures during the study and for at least 3 months after the completion of bevacizumab therapy
  • Patients who have a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipate the need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment on this study
  • Patients with active infection requiring parenteral antibiotics
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Hinsdale Hematology Oncology Associates Incorporated

    Hinsdale, Illinois, 60521

  • Sudarshan K Sharma MD Limted-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • University of Massachusetts Memorial Health Care

    Worcester, Massachusetts, 01605

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC# 704865) for Recurrent Sex Cord-Stromal Tumors of the Ovary

This phase II trial studies how well bevacizumab works in treating patients with sex cord-stromal tumors of the ovary that have come back. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the anti-tumor activity of bevacizumab by assessing frequency of objective response in patients with recurrent sex cord-stromal tumors of the ovary who have measurable disease.

SECONDARY OBJECTIVES:

  1. To determine the nature and degree of toxicity in these patients. II. To determine the overall survival and progression-free survival of these patients.

TERTIARY OBJECTIVES:

  1. To quantify expression of angiogenic or lymphangiogenic markers in recurrent stromal tumors of the ovary to determine the frequency of alterations and potential utility of biologic agents directed at these proteins for inclusion in future studies.

OUTLINE:

Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.

Being tested
Bevacizumab, Laboratory Biomarker Analysis
Medical subject headings
Granulosa cell tumor of the ovary, Ovarian gynandroblastoma, Sertoli-Leydig Cell Tumor

What participants receive

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

  • BevacizumabBiological

    Also called Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT00748657
Study groupRoleWhat they receive
Treatment (bevacizumab)ExperimentalPatients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Bevacizumab; Other: Laboratory Biomarker Analysis

What is being measured

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

  1. Tumor Response

    Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0

    Measured: Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels

Secondary outcomes (3)

  1. Progression-free Survival

    Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.

    Measured: Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels

  2. Overall Survival

    The observed length of life from entry into the study to death or the date of last contact.

    Measured: From study entry to death or last contact, up to 5 years.

  3. Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0

    Adverse Events at least possibly related to study agent.

    Measured: Up to 5 years

Timeline

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

  1. First posted8 Sep 2008 (estimated)
  2. Study start22 Sep 2008
  3. Primary completion31 Jan 2013
  4. Study completion31 Jan 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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00748657
Sponsor's protocol ID
NCI-2009-00611
Other IDs
NCI-2009-00611, CDR0000613531, GOG-0251, GOG-0251, GOG-0251, U10CA180868, U10CA027469
Status last verified
Jul 2019
First submitted
5 Sep 2008
Last updated
23 Jul 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab and Laboratory Biomarker Analysis in people with Malignant Ovarian Epithelial Tumor and Ovarian Granulosa Cell Tumor, run by National Cancer Institute (NCI) at 36 sites in United States.

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 16 inclusion and 22 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. 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 10 Jun 2015). 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?

Tumor Response (time frame: Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels). 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 NCT00748657.

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 23 Jul 2019.

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