SarcomaPhase 2NCT00003316
Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus
A Phase 2 study testing gemcitabine hydrochloride in people with Sarcoma, run by Gynecologic Oncology Group at 40 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with recurrent or refractory cancer of the uterus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sarcoma
- What is being tested?
- gemcitabine hydrochloride
- How many people
- Not given
- Where
- 40 sitesin 2 countries
- Study dates
- Aug 1998to Apr 2004
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or standard treatments Failed local therapeutic measures and considered incurable Measurable disease Not eligible for a higher priority GOG protocol
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection At least 5 years since any other invasive malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior gemcitabine No more than 1 prior chemotherapy regimen (single agent or combination therapy) Endocrine therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States39 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Cancer Center of Albany Medical Center
Albany, New York, 12208
Radiation Oncology Branch
Bethesda, Maryland, 20892
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
Tufts University School of Medicine
Boston, Massachusetts, 02111
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
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
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
CCOP - Kansas City
Kansas City, Missouri, 64131
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
Chao Family Comprehensive Cancer Center
Orange, California, 92868
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
University of Washington Medical Center
Seattle, Washington, 98195-6043
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Washington University School of Medicine
St Louis, Missouri, 63110
Tacoma General Hospital
Tacoma, Washington, 98405
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1082
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Evaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with recurrent or refractory cancer of the uterus.
Read the detailed description
OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II. Determine the toxicity of gemcitabine in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with partial response, complete response, or stable disease receive at least 3 courses of therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
- Conditions
- Sarcoma
- Being tested
- gemcitabine hydrochloride
- Keywords
- recurrent uterine sarcoma, uterine leiomyosarcoma
- Medical subject headings
- Sarcoma
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.
- First posted9 Apr 2004 (estimated)
- Study startAug 1998
- Primary completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Katherine Y. Look, MD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003316
- Sponsor's protocol ID
- CDR0000066265
- Other IDs
- GOG-131E
- Status last verified
- May 2004
- First submitted
- 6 Nov 2000
- Last updated
- 11 Apr 2013
- Results posted
- No
Publications
Look KY, Sandler A, Blessing JA, Lucci JA 3rd, Rose PG; Gynecologic Oncology Group (GOG) Study. Phase II trial of gemcitabine as second-line chemotherapy of uterine leiomyosarcoma: a Gynecologic Oncology Group (GOG) Study. Gynecol Oncol. 2004 Feb;92(2):644-7. doi: 10.1016/j.ygyno.2003.11.023.
PubMed 14766260
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
- ClinicalTrials.gov ID
- NCT00003316
- Acronym / sponsor ID
- CDR0000066265
- Conditions
- Sarcoma
- Keywords
- recurrent uterine sarcoma, uterine leiomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1998
- Primary completion
- Apr 2004 (actual)
- First posted
- 9 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with recurrent or refractory cancer of the uterus.
Detailed description
OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II. Determine the toxicity of gemcitabine in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with partial response, complete response, or stable disease receive at least 3 courses of therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
- Results publication: PubMed 14766260Look KY, Sandler A, Blessing JA, Lucci JA 3rd, Rose PG; Gynecologic Oncology Group (GOG) Study. Phase II trial of gemcitabine as second-line chemotherapy of uterine leiomyosarcoma: a Gynecologic Oncology Group (GOG) Study. Gynecol Oncol. 2004 Feb;92(2):644-7. doi: 10.1016/j.ygyno.2003.11.023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Y. Look, MD study chair
Indiana University
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine hydrochloride in people with Sarcoma, run by Gynecologic Oncology Group at 40 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
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 40 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 NCT00003316, 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.