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CompletedNCT00006028Updated May 27, 2013

Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy

A Phase 2 interventional study of cisplatin and gemcitabine hydrochloride in Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by Gynecologic Oncology Group. Completed at 31 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2013-05-27.

Sponsored by Gynecologic Oncology Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Sex
Female
01

Study 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.

Read the detailed description

OBJECTIVES:

  • Determine the anti-tumor activity of gemcitabine and cisplatin in patients with recurrent or refractory platinum-resistant ovarian epithelial cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols.
  • Determine the nature and degree of toxicity of this regimen in this patient population.
  • Correlate ex vivo drug sensitivity and resistance with clinical response to this regimen in these patients.
  • Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo measures of drug resistance in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.

02

Conditions studied

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer

Keywords

  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
03

In context

Ovarian Neoplasms

2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.

Browse Ovarian Neoplasms studies →

Lead sponsor

Gynecologic Oncology Group is the lead sponsor of 188 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
06

Study locations

31 sites
  • Community Hospital of Los Gatos
    Los Gatos, California 95032, United States
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612-9497, United States
  • Rush-Presbyterian-St. Luke's Medical Center
    Chicago, Illinois 60612-3864, United States
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637-1470, United States
  • Indiana University Cancer Center
    Indianapolis, Indiana 46202-5289, United States
  • Ellis Fischel Cancer Center
    Indianapolis, Indiana 46285, United States
  • Holden Comprehensive Cancer Center
    Iowa City, Iowa 52242-1009, United States
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    Bethesda, Maryland 20892-1182, United States
  • Tuft-New England Medical Center
    Boston, Massachusetts 02111, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216-4505, United States
  • Ellis Fischel Cancer Center - Columbia
    Columbia, Missouri 65203, United States
  • Cooper Hospital/University Medical Center
    Camden, New Jersey 08103-1489, United States
  • State University of New York Health Science Center at Brooklyn
    Brooklyn, New York 11203, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
  • State University of New York Health Sciences Center - Stony Brook
    Stony Brook, New York 11794-8091, United States
  • Lineberger Comprehensive Cancer Center, UNC
    Chapel Hill, North Carolina 27599-7295, United States
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
  • Comprehensive Cancer Center at Wake Forest University
    Winston-Salem, North Carolina 27157-1065, United States
  • Ireland Cancer Center
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195, United States
  • University of Oklahoma College of Medicine
    Oklahoma City, Oklahoma 73190, United States
  • Abington Memorial Hospital
    Abington, Pennsylvania 19001-3788, United States
  • Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033-0850, United States
  • University of Pennsylvania Cancer Center
    Philadelphia, Pennsylvania 19104-4283, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Brookview Research, Inc.
    Nashville, Tennessee 37203, United States
  • Simmons Cancer Center - Dallas
    Dallas, Texas 75390-9032, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555-0587, United States
  • CCOP - M.D. Anderson Research Base
    Houston, Texas 77030-4009, United States
  • University of Wisconsin Comprehensive Cancer Center
    Madison, Wisconsin 53792-6188, United States
  • Norwegian Radium Hospital
    Oslo, N-0310, Norway
07

References and documents

Publications

  • 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. PubMed 16643994 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2001 and a primary completion of Jan 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2000
First posted
Jan 27, 2003
Start
Jan 2001
Primary completionActual
Jan 2007
Last update
May 27, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00006028
First posted
Jan 27, 2003
Start date
Jan 2001
Primary completion
Jan 2007
Last update
May 27, 2013

Study contacts

Cheryl A. Brewer, MD
study chair · University of Illinois College of Medicine at Peoria
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2003. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Cisplatin · Gemcitabine

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