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A Phase II Evaluation of Belinostat (NSC #726630, IND #729990) and Carboplatin (NSC #241240) in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Brenner Tumor, Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Thank you

Trial Information

A Phase II Evaluation of Belinostat (NSC #726630, IND #729990) and Carboplatin (NSC #241240) in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer


PRIMARY OBJECTIVES:

I. 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.


Inclusion Criteria:



- 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

- 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

Exclusion Criteria:

- 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:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Don Dizon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2010-01663

NCT ID:

NCT00993616

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Brenner Tumor
  • Fallopian Tube Cancer
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Carcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Undifferentiated Adenocarcinoma
  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Brenner Tumor
  • Carcinoma
  • Cystadenocarcinoma
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Carcinoma, Endometrioid
  • Cystadenocarcinoma, Mucinous
  • Cystadenocarcinoma, Serous
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Abington Memorial HospitalAbington, Pennsylvania  19001
Hurley Medical CenterFlint, Michigan  48503
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Akron General Medical CenterAkron, Ohio  44302
Rush University Medical CenterChicago, Illinois  60612-3824
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Franklin Square Hospital CenterBaltimore, Maryland  21237
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
MetroHealth Medical CenterCleveland, Ohio  44109
Brigham and Women's HospitalBoston, Massachusetts  02115
Beebe Medical CenterLewes, Delaware  19958
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
North Kansas City HospitalKansas City, Missouri  64116
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Union Hospital of Cecil CountyElkton MD, Maryland  21921
University of North CarolinaChapel Hill, North Carolina  27599
Riverside Methodist HospitalColumbus, Ohio  43214
Indiana University Medical CenterIndianapolis, Indiana  46202
Hillcrest Hospital Cancer CenterMayfield Heights, Ohio  44124
M D Anderson Cancer CenterHouston, Texas  77030
University of CincinnatiCincinnati, Ohio  45267-0502
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Green Bay Oncology - EscanabaEscanaba, Michigan  49431
Green Bay Oncology - Iron MountainIron Mountain, Michigan  49801
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Saint Luke's Hospital of Kansas CityKansas City, Missouri  64111
Saint Joseph Health CenterKansas City, Missouri  64114
Truman Medical CenterKansas City, Missouri  64108
Cooper Hospital University Medical CenterCamden, New Jersey  08103
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology - Sturgeon BaySturgeon Bay, Wisconsin  54235
Cancer Care Associates-YaleTulsa, Oklahoma  74136-1929
Women and Infants HospitalProvidence, Rhode Island  02905
Lyndon Baines Johnson General HospitalHouston, Texas  77030
Stony Brook University Medical CenterStony Brook, New York  11794
Lahey Clinic Medical CenterBurlington, Massachusetts  01805
Holy Family Memorial HospitalManitowoc, Wisconsin  54221
Carilion Clinic Gynecological OncologyRoanoke, Virginia  24016
Women's Cancer Center of NevadaLas Vegas, Nevada  89109
Saint Luke's South HospitalOverland Park, Kansas  66213
Heartland Hematology and Oncology Associates IncorporatedKansas City, Missouri  64118
Saint Joseph Oncology IncSaint Joseph, Missouri  64507
University of Massachusetts Memorial Health CareWorcester, Massachusetts  01605
Door County Cancer CenterSturgeon Bay, Wisconsin  54235-1495
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Cleveland Clinic Cancer Center/Fairview HospitalCleveland, Ohio  44111
Mercy Cancer Center-West LakesClive, Iowa  50325
Mercy Medical Center-West LakesWest Des Moines, Iowa  50266