SarcomaPhase 3NCT00003128
Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cancer of the Uterus
A Phase 3 study testing filgrastim, ifosfamide and paclitaxel in people with Sarcoma, run by Gynecologic Oncology Group at 17 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide alone is more effective than ifosfamide plus paclitaxel in treating patients with 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?
- filgrastim, ifosfamide and paclitaxel
- How many people
- 166 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 1997to Feb 2007
- Phase
- Phase 3
- 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 stage III or IV, refractory, or recurrent heterologous or homologous carcinosarcoma (mixed mesodermal tumors) of the uterus
- Must not be amenable to curative-intent therapy
- Must have measurable disease consisting of abdominal, pelvic, chest or other masses that can be defined in at least 2 dimensions by palpation, x-ray, MRI, computed tomography or ultrasound
- If measured by MRI, computed tomography or ultrasound, the lesion must have a minimal tumor measurement of 1 cm
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Albumin at least 3 g/dL
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No history of congestive heart failure
- No unstable angina
- No myocardial infarction within the past 6 months
Other:
- No septicemia
- No severe infection
- No acute hepatitis
- No gastrointestinal bleeding
- At least 5 years since any other invasive malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for carcinosarcoma of the uterus
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 6 weeks since radiotherapy for current malignancy
- At least 3 months since radiotherapy if delivered to site of measurable disease
Surgery:
- Not specified
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
Tufts - New England Medical Center
Boston, Massachusetts, 02111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, 03756-0002
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
CCOP - Ochsner
New Orleans, Louisiana, 70121
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, 94305-5216
CCOP - Scott and White Hospital
Temple, Texas, 76508
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, 10466
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
About this study
Official title: A Phase III Trial of Ifosfamide (NSC #109274) Versus Ifosfamide Plus Paclitaxel (NSC #125973) in Patients With Advanced, 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. It is not yet known whether ifosfamide alone is more effective than ifosfamide plus paclitaxel in treating patients with cancer of the uterus.
PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with or without paclitaxel in treating patients with advanced, refractory, or recurrent cancer of the uterus.
Read the detailed description
OBJECTIVES:
- Determine whether the addition of paclitaxel to ifosfamide improves length of survival, progression free interval and response rate when compared to ifosfamide alone in patients with advanced, refractory or recurrent carcinosarcoma (mixed mesodermal tumors) of the uterus.
- Determine the toxicity of ifosfamide with paclitaxel in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to GOG performance status (GOG 0-1 vs GOG 2-3) and randomized to one of two treatment arms.
- Arm I: Patients receive ifosfamide IV daily for 3 days every 21 days.
- Arm II: Patients receive paclitaxel IV on day 1 and ifosfamide IV on days 1-3 every 21 days. Filgrastim (G-CSF) is given subcutaneously beginning on day 4 until granulocyte count is greater than 2,000/mm3. Paclitaxel therapy may precede or be given concurrently with ifosfamide.
Treatment for both arms continues for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, then every 6 months for an additional 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 166 patients (83 per arm) will be accrued for this study within approximately 5.5 years.
- Conditions
- Sarcoma
- Being tested
- filgrastim, ifosfamide, paclitaxel
- Keywords
- stage III uterine sarcoma, stage IV uterine sarcoma, 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.
filgrastimBiological
ifosfamideDrug
paclitaxelDrug
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 startNov 1997
- Primary completionFeb 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group
- Investigators
- Howard D. Homesley, MD, Study chair, Gynecologic Oncology NetworkHiginia R. Cardenes, MD, PhD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003128
- Sponsor's protocol ID
- CDR0000065891
- Other IDs
- GOG-0161, ECOG-G0161
- Status last verified
- May 2004
- First submitted
- 1 Nov 1999
- Last updated
- 9 Jul 2013
- Results posted
- No
Publications
Homesley HD, Filiaci V, Markman M, Bitterman P, Eaton L, Kilgore LC, Monk BJ, Ueland FR; Gynecologic Oncology Group. Phase III trial of ifosfamide with or without paclitaxel in advanced uterine carcinosarcoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Feb 10;25(5):526-31. doi: 10.1200/JCO.2006.06.4907.
PubMed 17290061
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial of Ifosfamide (NSC #109274) Versus Ifosfamide Plus Paclitaxel (NSC #125973) in Patients With Advanced, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus
- ClinicalTrials.gov ID
- NCT00003128
- Acronym / sponsor ID
- CDR0000065891
- Conditions
- Sarcoma
- Keywords
- stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine carcinosarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group
- Study start
- Nov 1997
- Primary completion
- Feb 2007 (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. It is not yet known whether ifosfamide alone is more effective than ifosfamide plus paclitaxel in treating patients with cancer of the uterus.
PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with or without paclitaxel in treating patients with advanced, refractory, or recurrent cancer of the uterus.
Detailed description
OBJECTIVES:
- Determine whether the addition of paclitaxel to ifosfamide improves length of survival, progression free interval and response rate when compared to ifosfamide alone in patients with advanced, refractory or recurrent carcinosarcoma (mixed mesodermal tumors) of the uterus.
- Determine the toxicity of ifosfamide with paclitaxel in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to GOG performance status (GOG 0-1 vs GOG 2-3) and randomized to one of two treatment arms.
- Arm I: Patients receive ifosfamide IV daily for 3 days every 21 days.
- Arm II: Patients receive paclitaxel IV on day 1 and ifosfamide IV on days 1-3 every 21 days. Filgrastim (G-CSF) is given subcutaneously beginning on day 4 until granulocyte count is greater than 2,000/mm3. Paclitaxel therapy may precede or be given concurrently with ifosfamide.
Treatment for both arms continues for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, then every 6 months for an additional 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 166 patients (83 per arm) will be accrued for this study within approximately 5.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
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 |
|---|---|---|
| filgrastim | Biological | – |
| ifosfamide | Drug | – |
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
- Results publication: PubMed 17290061Homesley HD, Filiaci V, Markman M, Bitterman P, Eaton L, Kilgore LC, Monk BJ, Ueland FR; Gynecologic Oncology Group. Phase III trial of ifosfamide with or without paclitaxel in advanced uterine carcinosarcoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Feb 10;25(5):526-31. doi: 10.1200/JCO.2006.06.4907.
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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.
Howard D. Homesley, MD study chair
Gynecologic Oncology Network
Higinia R. Cardenes, MD, PhD study chair
Indiana University
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing filgrastim, ifosfamide and paclitaxel in people with Sarcoma, run by Gynecologic Oncology Group at 17 sites in United States.
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: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00003128, 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 9 Jul 2013.