Ovarian CancerPhase 2NCT00002526
Chemotherapy in Treating Patients With Advanced Sarcoma
A Phase 2 study testing filgrastim, doxorubicin hydrochloride and ifosfamide in people with Ovarian Cancer and Sarcoma, run by Swiss Cancer Institute at 1 site in Switzerland.
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 combination chemotherapy consisting of ifosfamide and doxorubicin in patients with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ovarian Cancer, Sarcoma
- What is being tested?
- filgrastim, doxorubicin hydrochloride and ifosfamide
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 1993to Sep 1995
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven advanced soft tissue or gynecologic sarcoma Measurable disease No brain metastases (CT scan required if metastases are clinically suspected)
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Liver function tests no greater than 2 times normal Albumin 4.0-6.0 g/dL Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac function normal by MUGA scan or echocardiogram Other: No other prior or concurrent malignancy except radically removed nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the bladder No prior radiotherapy to indicator lesion Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
About this study
Official title: Continuous 5 Days Infusion of High Dose Ifosfamide and Adriamycin in Patients With Advanced Sarcoma
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 combination chemotherapy consisting of ifosfamide and doxorubicin in patients with advanced sarcoma.
Read the detailed description
OBJECTIVES: I. Determine the response rate, time to treatment failure, and survival in patients with advanced soft tissue or gynecological sarcoma treated with high-dose ifosfamide and doxorubicin.
OUTLINE: Patients receive ifosfamide IV continuously on days 1-5 and doxorubicin IV on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing through day 16 (or until day 20 if blood counts have not recovered by day 16). Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at treatment failure and then annually thereafter.
PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study.
- Conditions
- Ovarian Cancer, Sarcoma
- Being tested
- filgrastim, doxorubicin hydrochloride, ifosfamide
- Keywords
- stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, ovarian sarcoma, stage IV adult soft tissue sarcoma
- Medical subject headings
- Ovarian Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
ifosfamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2004 (estimated)
- Study startJan 1993
- Primary completionSep 1995
- Study completionSep 1995
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 Ovarian CancerStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge Leyvraz, MD, Study chair, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002526
- Sponsor's protocol ID
- SAKK 57/93
- Other IDs
- EU-93004
- Status last verified
- May 2012
- First submitted
- 1 Nov 1999
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leyvraz S, Zweifel M, Jundt G, Lissoni A, Cerny T, Sessa C, Fey M, Dietrich D, Honegger HP; Swiss Group for Clinical Cancer Research. Long-term results of a multicenter SAKK trial on high-dose ifosfamide and doxorubicin in advanced or metastatic gynecologic sarcomas. Ann Oncol. 2006 Apr;17(4):646-51. doi: 10.1093/annonc/mdl020. Epub 2006 Feb 24.
PubMed 16500907
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous 5 Days Infusion of High Dose Ifosfamide and Adriamycin in Patients With Advanced Sarcoma
- ClinicalTrials.gov ID
- NCT00002526
- Acronym / sponsor ID
- SAKK 57/93
- Conditions
- Ovarian Cancer, Sarcoma
- Keywords
- stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, ovarian sarcoma, stage IV adult soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Jan 1993
- Primary completion
- Sep 1995 (actual)
- Study completion
- Sep 1995 (actual)
- First posted
- 11 Mar 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of ifosfamide and doxorubicin in patients with advanced sarcoma.
Detailed description
OBJECTIVES: I. Determine the response rate, time to treatment failure, and survival in patients with advanced soft tissue or gynecological sarcoma treated with high-dose ifosfamide and doxorubicin.
OUTLINE: Patients receive ifosfamide IV continuously on days 1-5 and doxorubicin IV on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing through day 16 (or until day 20 if blood counts have not recovered by day 16). Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at treatment failure and then annually thereafter.
PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- 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 | – |
| doxorubicin hydrochloride | Drug | – |
| ifosfamide | 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 15 May 2012.
- Results publication: PubMed 16500907Leyvraz S, Zweifel M, Jundt G, Lissoni A, Cerny T, Sessa C, Fey M, Dietrich D, Honegger HP; Swiss Group for Clinical Cancer Research. Long-term results of a multicenter SAKK trial on high-dose ifosfamide and doxorubicin in advanced or metastatic gynecologic sarcomas. Ann Oncol. 2006 Apr;17(4):646-51. doi: 10.1093/annonc/mdl020. Epub 2006 Feb 24.
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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.
Serge Leyvraz, MD study chair
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, doxorubicin hydrochloride and ifosfamide in people with Ovarian Cancer and Sarcoma, run by Swiss Cancer Institute at 1 site in Switzerland.
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 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 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 NCT00002526, 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 15 May 2012.