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Brenner TumorPhase 2NCT00993616

Belinostat and Carboplatin in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Carboplatin or Cisplatin

A Phase 2 study testing belinostat and carboplatin in people with Brenner Tumor and Fallopian Tube Cancer, run by National Cancer Institute (NCI) at 81 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 is studying how well giving belinostat together with carboplatin works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to carboplatin or cisplatin. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
belinostat and carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
81 sitesUnited States
Study dates
Dec 2009to 29 Jul 2012
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 must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
  • Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.)
  • All patients must have measurable disease as defined by RECIST 1.1; measureable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must not be eligible for a higher priority GOG protocol, if one exists; in general, this would refer to any active GOG Phase III or Rare Tumor protocol for the same patient population
  • Patients must have a GOG Performance Status of 0, 1, or 2
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  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI)
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
  • Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included non-cytotoxic therapy, intraperitoneal therapy, high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • Patients must be considered platinum resistant or refractory according to the following criteria:
  • Patients must have had progression of disease on or within 6 months of their last platinum dose
  • Progression of disease is defined according to RECIST 1.1
  • The development of CA125 elevation on or within 6 months of last platinum treatment, in the absence of radiographic progression according to RECIST 1.1, is not considered platinum resistance for the purposes of this study
  • Patients who have NOT received prior therapy with taxane-based chemotherapy MUST receive a second regimen that includes paclitaxel or docetaxel
  • Patients must be considered paclitaxel-resistant, i.e., have had a treatment-free interval following paclitaxel of less than six months, or have progressed during paclitaxel-based therapy
  • Patients must have NOT received any additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens except as noted above; (note: Optimal evaluation of the safety and efficacy of new chemotherapy regimens is best performed in patients with minimal prior therapy; non-investigational therapy, such as retreatment with platinum and/or paclitaxel, is non-curative in the setting of recurrent disease, and can generally be safely administered to patients following participation in a phase II trial)
  • Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
  • Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to the NCI Common Terminology Criteria (CTCAE v3.0) grade 1
  • Platelets greater than or equal to 100,000/mcl
  • Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), per CTCAE v.3.0 grade 1
  • Bilirubin less than or equal to 1.5 x ULN (CTCAE v.3.0 grade 1)
  • SGOT (AST) less than or equal to 3 x ULN (per the CTCAE v.3.0 grade 1)
  • Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v.3.0 grade 1)
  • Neuropathy (sensory and motor) less than or equal to the CTCAE v3.0 grade 1
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must meet pre-entry requirements
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception

Who cannot join

  • Patients who have had prior therapy with Belinostat (PXD101) or other HDAC inhibitors
  • Patients who have received radiation to more than 25% of marrow-bearing areas
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, and other specific malignancies as noted below, 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
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian cancer are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients must not use concomitant medications on PXD infusion days that may cause Torsade de Pointes; medications associated with this risk include:
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  • Amiodarone, Arsenic trioxide, Bepridil, Cisapride, Disopyramide, Dofetilide, Droperidol, Erythromycin, Felbamate, Flecainide, Fluoxetine, Halofantrine, Haloperidol, Ibutilide, Levofloxacin, Mesoridazine, Pentamidine, Procainamide, Quinidine, Sotalol, Sparfloxacin, or Thioridazine
  • Patients with significant cardiovascular disease defined as:
  • Unstable angina pectoris, uncontrolled hypertension (blood pressure > 150/90 despite maximal medical therapy), congestive heart failure related to primary cardiac disease, any condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or history of myocardial infarction within 6 months of trial entry
  • Patients who are pregnant or nursing

Trial locations and contacts

81 sites in 1 country.

81 sites in 1 country

United States81 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium Community Clinical Oncology Program

    Ann Arbor, Michigan, 48106

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Oakwood Hospital

    Dearborn, Michigan, 48124

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49431

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Allegiance Health

    Jackson, Michigan, 49201

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Green Bay Oncology - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia, 24016

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Saint Joseph Oncology Inc

    Saint Joseph, Missouri, 64507

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Door County Cancer Center

    Sturgeon Bay, Wisconsin, 54235-1495

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Tulsa Cancer Institute

    Tulsa, Oklahoma, 74146

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • University of Massachusetts Memorial Health Care

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Phase II Evaluation of Belinostat (NSC #726630) and Carboplatin (NSC #241240) in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

This phase II trial is studying how well giving belinostat together with carboplatin works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to carboplatin or cisplatin. Belinostat 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. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving belinostat together with carboplatin may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the antitumor activity of belinostat and carboplatin in patients with persistent or recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, measured by objective response rate and the frequency of progression- free survival at 6 months.

II. To determine the nature and degree of toxicity of belinostat in combination with carboplatin in this cohort of patients.

OUTLINE: This is a multicenter study.

Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.

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

Being tested
belinostat, carboplatin
Medical subject headings
Brenner Tumor, 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.

  • belinostatDrug

    Also called PXD101

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

Study groups in NCT00993616
Study groupRoleWhat they receive
TreatmentExperimentalPatients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.
Receives: Drug: belinostat; Drug: carboplatin

What is being measured

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

  1. Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1)

    Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (version 1.1): Complete Response (CR) is disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Increasing Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest

    Measured: From study entry, up to 5 years

  2. Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0

    Measured: Every cycle during treatment and 30 days after the end of treatment

  3. Progression Free Survival at 6 Months

    Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

    Measured: Every other cycle for 6 months

Timeline

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

  1. First posted12 Oct 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionJul 2012
  4. Study completion29 Jul 2012

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00993616
Sponsor's protocol ID
NCI-2010-01663
Other IDs
NCI-2010-01663, CDR0000656707, GOG-0126T, GOG-0126T, U10CA027469
Status last verified
Jul 2019
First submitted
9 Oct 2009
Last updated
23 Jul 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing belinostat and carboplatin in people with Brenner Tumor and Fallopian Tube Cancer, run by National Cancer Institute (NCI) at 81 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 30 inclusion and 10 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 81 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 21 Jan 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 by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1) (time frame: From study entry, up to 5 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 NCT00993616.

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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