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

NCT00993616 | Completed Phase 2 Results

• 4 other identifiers: NCI-2010-01663CDR0000656707GOG-0126TU10CA027469
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 81

Brief 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

  From study entry, up to 5 years

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

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

• 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.

  Every other cycle for 6 months

Other Outcomes (1)

• Duration of Progression-free Interval for All Patients

  up to 5 years

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: belinostat; Drug: carboplatin

Interventions

belinostat DRUG

Given IV

Also known as: PXD101

Treatment

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Gynecologic Oncology Group: collaborator

Study Sites (81)

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, 50325, United States

Location

Mercy Cancer Center-West Lakes

Clive, Iowa, 50325, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Iowa Oncology Research Association CCOP

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, 50314, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Mercy Medical Center-West Lakes

West Des Moines, Iowa, 50266, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Saint Luke's South Hospital

Overland Park, Kansas, 66213, United States

Location

Shawnee Mission Medical Center

Shawnee Mission, Kansas, 66204, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Union Hospital of Cecil County

Elkton, Maryland, 21921, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

University of Massachusetts Memorial Health Care

Worcester, Massachusetts, 01605, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

Michigan Cancer Research Consortium Community Clinical Oncology Program

Ann Arbor, Michigan, 48106, United States

Location

Oakwood Hospital

Dearborn, Michigan, 48124, United States

Location

Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Green Bay Oncology - Escanaba

Escanaba, Michigan, 49431, United States

Location

Hurley Medical Center

Flint, Michigan, 48502, United States

Location

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, 48532, United States

Location

Green Bay Oncology - Iron Mountain

Iron Mountain, Michigan, 49801, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Saint Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Saint Joseph Mercy Oakland

Pontiac, Michigan, 48341-2985, United States

Location

Saint Joseph Mercy Port Huron

Port Huron, Michigan, 48060, United States

Location

Saint Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Saint Joseph Health Center

Kansas City, Missouri, 64114, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

Heartland Hematology and Oncology Associates Incorporated

Kansas City, Missouri, 64118, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, 64086, United States

Location

Liberty Hospital

Liberty, Missouri, 64068, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Saint Joseph Oncology Inc

Saint Joseph, Missouri, 64507, United States

Location

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Tulsa Cancer Institute

Tulsa, Oklahoma, 74146, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Lyndon Baines Johnson General Hospital

Houston, Texas, 77026-1967, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Carilion Clinic Gynecological Oncology

Roanoke, Virginia, 24016, United States

Location

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, 54301-3526, United States

Location

Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

Green Bay Oncology Limited at Saint Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

Saint Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

Holy Family Memorial Hospital

Manitowoc, Wisconsin, 54221, United States

Location

Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Green Bay Oncology - Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

Location

Door County Cancer Center

Sturgeon Bay, Wisconsin, 54235-1495, United States

Location

Green Bay Oncology - Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235, United States

Location

MeSH Terms

Conditions

Brenner Tumor; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

belinostat; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Neoplasms by Site; Fallopian Tube Diseases; Carcinoma; Endocrine Gland Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Melissa Leventhal
• Organization: Gynecologic Oncology Group Statistical and Data Center

mleventhal@gogstats.org

716-845-4030

Study Officials

• Don Dizon

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2009
• First Posted: October 12, 2009
• Study Start: December 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 29, 2012
• Last Updated: July 23, 2019
• Results First Posted: January 21, 2014

Record last verified: 2019-07

Locations

US (81)