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Ovarian CancerPhase 2NCT00006028

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 study testing cisplatin and gemcitabine hydrochloride in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 31 sites in 2 countries.

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

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… Read more about this study

Who is it for?
Any age, women only
What is being tested?
cisplatin and gemcitabine hydrochloride
How many people
Not given
Where
31 sitesin 2 countries
Study dates
Jan 2001to Jan 2007
Phase
Phase 2
Are there results?
None posted in the registry

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

31 sites in 2 countries.

31 sites in 2 countries

United States30 sites
  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001-3788

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • Tuft-New England Medical Center

    Boston, Massachusetts, 02111

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Cooper Hospital/University Medical Center

    Camden, New Jersey, 08103-1489

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612-3864

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Ireland Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75390-9032

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0587

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • CCOP - M.D. Anderson Research Base

    Houston, Texas, 77030-4009

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Ellis Fischel Cancer Center

    Indianapolis, Indiana, 46285

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242-1009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Community Hospital of Los Gatos

    Los Gatos, California, 95032

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6188

  • Brookview Research, Inc.

    Nashville, Tennessee, 37203

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73190

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11794-8091

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1065

Other trials in United States

Norway1 site
  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

About this study

Official title: Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

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.

Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2001
  3. Primary completionJan 2007

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006028
Sponsor's protocol ID
CDR0000068041
Other IDs
GOG-0126L
Status last verified
Mar 2003
First submitted
5 Jul 2000
Last updated
27 May 2013
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin and gemcitabine hydrochloride in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 31 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Norway. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006028, which also lists 1 linked publication.

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 27 May 2013.

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