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Cervical CancerPhase 2NCT00006482

Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix

A Phase 2 study testing cisplatin and gemcitabine hydrochloride in people with Cervical Cancer, run by Gynecologic Oncology Group at 34 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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 combining gemcitabine and cisplatin in treating patients who have refractory or recurrent… Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Cervical Cancer
What is being tested?
cisplatin and gemcitabine hydrochloride
How many people
Not given
Where
34 sitesin 2 countries
Study dates
Oct 2000to Apr 2006
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 refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapy and is considered incurable
  • Must have had 1 prior chemotherapy regimen for cervical cancer
  • No more than 1 prior chemotherapy regimen (single or combination drug therapy), unless used as a radiosensitizer
  • No prior chemotherapy for recurrent or persistent disease including retreatment with initial chemotherapy
  • Bidimensionally measurable disease
  • Ineligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count at least lower limit of normal
  • Absolute neutrophil count at least 1,500/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT and alkaline phosphatase no greater than 3 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • Not pregnant
  • Fertile patients must use effective contraception
  • No significant infection
  • No other malignancies within past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior biologic therapy for cervical cancer

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy for cervical cancer and recovered
  • No prior gemcitabine

Endocrine therapy:

  • At least 3 weeks since prior endocrine therapy for cervical cancer

Radiotherapy:

  • At least 3 weeks since prior radiotherapy for cervical cancer and recovered
  • No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery:

  • At least 3 weeks since prior surgery for cervical cancer and recovered

Other:

  • No concurrent amifostine or other protective reagents
  • No prior anticancer therapy that contraindicates study

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States33 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Tufts University School of Medicine

    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

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

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

    Chicago, Illinois, 60612

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45267-0502

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • Rational Therapeutics Inc.

    Long Beach, California, 90807

  • Community Hospital of Los Gatos

    Los Gatos, California, 95032

  • Schneider Children's Hospital at North Shore

    Manhasset, New York, 11030

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73190

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • University of Illinois College of Medicine at Peoria

    Peoria, Illinois, 61603

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Tacoma General Hospital

    Tacoma, Washington, 98405

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

Other trials in United States

Canada1 site

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

Other trials in Canada

About this study

Official title: A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

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 combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.

Read the detailed description

OBJECTIVES:

  • Determine the antitumor activity of gemcitabine and cisplatin in patients with refractory or recurrent squamous cell carcinoma of the cervix.
  • Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV and gemcitabine IV over 1 hour on days 1 and 8. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 28-69 patients will be accrued for this study.

Conditions
Cervical Cancer
Keywords
recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma
Medical subject headings
Uterine Cervical Neoplasms

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 posted8 Oct 2003 (estimated)
  2. Study startOct 2000
  3. Primary completionApr 2006

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
NCT00006482
Sponsor's protocol ID
CDR0000068313
Other IDs
GOG-0127Q
Status last verified
May 2004
First submitted
6 Nov 2000
Last updated
11 Apr 2013
Results posted
No

Publications

  • Brewer CA, Blessing JA, Nagourney RA, McMeekin DS, Lele S, Zweizig SL. Cisplatin plus gemcitabine in previously treated squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Feb;100(2):385-8. doi: 10.1016/j.ygyno.2005.09.009. Epub 2005 Nov 4.

    PubMed 16271750

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin and gemcitabine hydrochloride in people with Cervical Cancer, run by Gynecologic Oncology Group at 34 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: stopped early, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Canada. 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 was stopped early. Results are not available in the source record.

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 NCT00006482, 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 11 Apr 2013.

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