NCT00006028

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2000

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

May 27, 2013

Status Verified

March 1, 2003

Enrollment Period

6 years

First QC Date

July 5, 2000

Last Update Submit

May 24, 2013

Conditions

Ovarian CancerPrimary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancerprimary peritoneal cavity cancer

Interventions

cisplatinDRUG
gemcitabine hydrochlorideDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed primary ovarian epithelial cancer or primary peritoneal carcinoma * Recurrent or persistent disease * Bidimensionally measurable disease by physical examination or medical imaging techniques * Sonography is acceptable if lesions are clearly defined on initial examination and bidimensionally measurable * Ascites and pleural effusions are not considered measurable disease * Must not be eligible for a higher priority Gynecologic Oncology Group protocol * Must have received one, and only one, prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease * Initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment * If no prior paclitaxel, a second regimen containing paclitaxel allowed * Platinum-resistant or refractory (i.e., treatment-free interval after platinum-based therapy of less than 6 months or progressed during platinum-based therapy) PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No other malignancy within the past 5 years except nonmelanoma skin cancer * Sensory and motor neuropathy no greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic or immunologic therapy for ovarian or peritoneal cancer Chemotherapy: * See Disease Characteristics * No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens * No prior gemcitabine * At least 3 weeks since prior chemotherapy for ovarian or peritoneal cancer and recovered Endocrine therapy: * At least 1 week since prior hormonal therapy for ovarian or peritoneal cancer * Concurrent continuation of hormonal replacement therapy allowed Radiotherapy: * At least 3 weeks since prior radiotherapy for ovarian or peritoneal cancer and recovered * No prior radiotherapy to only site of measurable disease * No prior radiotherapy to more than 25% of bone marrow Surgery: * See Disease Characteristics * At least 3 weeks since prior surgery for ovarian or peritoneal cancer and recovered Other: * At least 3 weeks since other prior therapy for ovarian or peritoneal cancer * No prior cancer treatment that would preclude study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (31)

Community Hospital of Los Gatos

Los Gatos, California, 95032, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612-3864, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Ellis Fischel Cancer Center

Indianapolis, Indiana, 46285, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Tuft-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

Cooper Hospital/University Medical Center

Camden, New Jersey, 08103-1489, United States

Location

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, 11203, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11794-8091, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1065, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73190, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001-3788, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Brookview Research, Inc.

Nashville, Tennessee, 37203, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75390-9032, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

CCOP - M.D. Anderson Research Base

Houston, Texas, 77030-4009, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6188, United States

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Related Publications (1)

  • Brewer CA, Blessing JA, Nagourney RA, Morgan M, Hanjani P. Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Nov;103(2):446-50. doi: 10.1016/j.ygyno.2006.03.018. Epub 2006 Apr 27.

    PMID: 16643994RESULT

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

CisplatinGemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Cheryl A. Brewer, MD

    University of Illinois College of Medicine at Peoria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

January 1, 2001

Primary Completion

January 1, 2007

Last Updated

May 27, 2013

Record last verified: 2003-03

Locations

US(30)NO(1)