SarcomaPhase 2NCT00003156
Topotecan in Treating Patients With Recurrent or Refractory Cancer of the Uterus
A Phase 2 study testing topotecan hydrochloride in people with Sarcoma, run by Gynecologic Oncology Group at 46 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 topotecan in treating patients with recurrent or refractory cancer of the uterus. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Sarcoma
- What is being tested?
- topotecan hydrochloride
- How many people
- Not given
- Where
- 46 sitesin 2 countries
- Study dates
- Jun 1998to Oct 2005
- 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 proven recurrent or refractory carcinosarcoma (mixed mesodermal tumors) of the uterus Measurable disease
PATIENT CHARACTERISTICS: Age: Not specified Performance Status: GOG 0-2 Life Expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 20 mL/min Other: No invasive malignancies within the past 5 years except nonmelanomatous skin cancer No significant infection
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 topotecan or camptothecin therapy No more than 1 prior chemotherapy regimen (either single or combination chemotherapy) Endocrine therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Prior surgery allowed and recovered
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
United States45 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
Fletcher Allen Health Care
Burlington, Vermont, 05401
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908
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
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
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
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Community Hospital of Los Gatos
Los Gatos, California, 95032
North Shore University Hospital
Manhasset, New York, 11030
CCOP - Baptist Cancer Institute
Memphis, Tennessee, 38117
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Brookview Research, Inc.
Nashville, Tennessee, 37203
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
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
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
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
Tacoma General Hospital
Tacoma, Washington, 98405
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
CCOP - Scott and White Hospital
Temple, Texas, 76508
CCOP - Sooner State
Tulsa, Oklahoma, 74136
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
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
About this study
Official title: Evaluation of Topotecan in the Treatment of Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) 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 topotecan in treating patients with recurrent or refractory cancer of the uterus.
Read the detailed description
OBJECTIVES: I. Estimate the antitumor activity of topotecan in patients with recurrent or refractory carcinosarcoma of the uterus who have failed standard therapy. II. Determine the nature and degree of toxic effects of topotecan in these patients.
OUTLINE: Patients receive topotecan IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for a minimum of 1 course in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease continue treatment for at least three courses. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then periodically thereafter until death.
PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 2 years.
- Conditions
- Sarcoma
- Being tested
- topotecan hydrochloride
- Keywords
- recurrent uterine sarcoma, uterine carcinosarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topotecan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2004 (estimated)
- Study startJun 1998
- Primary completionOct 2005
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
- David S. Miller, MD, Study chair, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003156
- Sponsor's protocol ID
- CDR0000065948
- Other IDs
- GOG-130D
- Status last verified
- Jan 2006
- First submitted
- 6 Nov 2000
- Last updated
- 11 Apr 2013
- Results posted
- No
Publications
Miller DS, Blessing JA, Schilder J, Munkarah A, Lee YC. Phase II evaluation of topotecan in carcinosarcoma of the uterus: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Aug;98(2):217-21. doi: 10.1016/j.ygyno.2005.05.015.
PubMed 15975641
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 Topotecan in the Treatment of Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus
- ClinicalTrials.gov ID
- NCT00003156
- Acronym / sponsor ID
- CDR0000065948
- Conditions
- Sarcoma
- Keywords
- recurrent uterine sarcoma, uterine carcinosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 1998
- Primary completion
- Oct 2005 (actual)
- First posted
- 7 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 topotecan in treating patients with recurrent or refractory cancer of the uterus.
Detailed description
OBJECTIVES: I. Estimate the antitumor activity of topotecan in patients with recurrent or refractory carcinosarcoma of the uterus who have failed standard therapy. II. Determine the nature and degree of toxic effects of topotecan in these patients.
OUTLINE: Patients receive topotecan IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for a minimum of 1 course in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease continue treatment for at least three courses. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then periodically thereafter until death.
PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| topotecan 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 15975641Miller DS, Blessing JA, Schilder J, Munkarah A, Lee YC. Phase II evaluation of topotecan in carcinosarcoma of the uterus: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Aug;98(2):217-21. doi: 10.1016/j.ygyno.2005.05.015.
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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.
David S. Miller, MD study chair
Simmons Cancer Center
46 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 topotecan hydrochloride in people with Sarcoma, run by Gynecologic Oncology Group at 46 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 46 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 NCT00003156, 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.