SarcomaPhase 2NCT00033644
Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
A Phase 2 study testing sargramostim, cisplatin and dacarbazine in people with Sarcoma, run by Gynecologic Oncology Group at 21 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. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of… 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?
- sargramostim, cisplatin and dacarbazine
- How many people
- Not given
- Where
- 21 sitesin 2 countries
- Study dates
- Mar 2002to 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed primary leiomyosarcoma (LMS) of the uterus
- Advanced, persistent, or recurrent disease that is refractory to curative therapy or established treatments
- At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR
- At least 10 mm by spiral CT scan
- Tumors within a previously irradiated field are designated as non-target lesions
- Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists), including any active phase III protocol for the same population
PATIENT CHARACTERISTICS:
Age:
- 18 and over
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:
- No active infection requiring antibiotics
- No grade 2 or greater sensory or motor neuropathy
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior cytotoxic chemotherapy for LMS of the uterus
Endocrine therapy:
- At least 1 week since prior hormonal therapy for LMS of the uterus
- Concurrent hormone replacement therapy allowed
Radiotherapy:
- See Disease Characteristics
- Recovered from prior recent radiotherapy
Surgery:
- Recovered from prior recent surgery
Other:
- Recovered from other prior recent therapy
- No prior cancer treatment that would preclude study therapy
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 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
Cooper University Hospital
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
Barrett Cancer Center
Cincinnati, Ohio, 45267-0526
University of Colorado Cancer Center
Denver, Colorado, 80010
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
University of Texas Medical Branch
Galveston, Texas, 77555-0587
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905-0001
Washington University School of Medicine
St Louis, Missouri, 63110
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
Tacoma General Hospital
Tacoma, Washington, 98405
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1065
About this study
Official title: A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.
Read the detailed description
OBJECTIVES:
- Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5 minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients achieving complete or partial response receive a maximum of 6 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.
- Conditions
- Sarcoma
- Being tested
- sargramostim, cisplatin, dacarbazine, doxorubicin hydrochloride, mitomycin C
- Keywords
- stage IV uterine sarcoma, 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.
sargramostimBiological
cisplatinDrug
dacarbazineDrug
mitomycin CDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2002
- 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
- Harry J. Long, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033644
- Sponsor's protocol ID
- CDR0000069308
- Other IDs
- GOG-0087K
- Status last verified
- Sep 2004
- First submitted
- 9 Apr 2002
- Last updated
- 11 Apr 2013
- Results posted
- No
Publications
Long HJ 3rd, Blessing JA, Sorosky J. Phase II trial of dacarbazine, mitomycin, doxorubicin, and cisplatin with sargramostim in uterine leiomyosarcoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Nov;99(2):339-42. doi: 10.1016/j.ygyno.2005.06.002. Epub 2005 Jul 26.
PubMed 16051328
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
- A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
- ClinicalTrials.gov ID
- NCT00033644
- Acronym / sponsor ID
- CDR0000069308
- Conditions
- Sarcoma
- Keywords
- stage IV uterine sarcoma, 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
- Mar 2002
- Primary completion
- Oct 2005 (actual)
- First posted
- 27 Jan 2003 (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. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.
Detailed description
OBJECTIVES:
- Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5 minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients achieving complete or partial response receive a maximum of 6 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.
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 |
|---|---|---|
| sargramostim | Biological | – |
| cisplatin | Drug | – |
| dacarbazine | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| mitomycin C | 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 16051328Long HJ 3rd, Blessing JA, Sorosky J. Phase II trial of dacarbazine, mitomycin, doxorubicin, and cisplatin with sargramostim in uterine leiomyosarcoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Nov;99(2):339-42. doi: 10.1016/j.ygyno.2005.06.002. Epub 2005 Jul 26.
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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.
Harry J. Long, MD study chair
Mayo Clinic
21 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 sargramostim, cisplatin and dacarbazine in people with Sarcoma, run by Gynecologic Oncology Group at 21 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 21 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 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 NCT00033644, 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.