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SarcomaPhase 1NCT00030784

Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

A Phase 1 study testing ifosfamide and pegylated liposomal doxorubicin hydrochloride in people with Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 I trial to study the effectiveness of combining liposomal doxorubicin with ifosfamide in treating patients who have advanced or… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Sarcoma
What is being tested?
ifosfamide and pegylated liposomal doxorubicin hydrochloride
How many people
28 participants
Where
2 sitesin 2 countries
Study dates
Nov 2001to Mar 2005
Phase
Phase 1
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 confirmed soft tissue sarcoma
  • Advanced and/or metastatic disease
  • Must be of any of the following types:
  • Malignant fibrous histiocytoma
  • Liposarcoma (excluding lipomas and well-differentiated liposarcomas)
  • Rhabdomyosarcoma
  • Synovial sarcoma
  • Malignant paraganglioma
  • Fibrosarcoma
  • Leiomyosarcoma
  • Angiosarcoma
  • Neurogenic sarcoma
  • Sarcoma not otherwise specified
  • Paraffin blocks and slides must be available
  • Measurable disease
  • Osseous lesions and pleural effusions are not considered measurable disease
  • Evidence of progressive disease within the past 6 weeks
  • The following conditions are excluded:
  • Gastrointestinal stromal tumors
  • Malignant mesothelioma
  • Chondrosarcoma
  • Neuroblastoma
  • Osteosarcoma
  • Ewing's sarcoma
  • Embryonal rhabdomyosarcoma
  • No symptomatic or known CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 to 70

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.75 mg/dL
  • Albumin at least 2.5 g/dL

Renal:

  • Creatinine no greater than 1.4 mg/dL
  • Creatinine clearance at least 65 mL/min

Cardiovascular:

  • Ejection fraction at least 50% by echocardiogram or isotopic methods
  • No history of cardiovascular disease

Other:

  • No other prior or concurrent primary malignancies except adequately treated carcinoma in situ of the cervix or basal cell carcinoma
  • No other severe medical illness
  • No psychosis
  • No psychological, familial, sociological, or geographical condition that would preclude study participation
  • Not pregnant
  • Fertile patients must use effective contraception (barrier method for men) during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for advanced disease
  • No other concurrent systemic chemotherapy for malignancy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to sole indicator lesion
  • Concurrent radiotherapy allowed except to sole indicator lesion

Surgery:

  • Not specified

Other:

  • No other concurrent investigational drugs

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Denmark1 site

  • Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

    Aarhus, DK-8000

Other trials in Denmark

Germany1 site

  • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

    Berlin, D-13122

Other trials in Germany

About this study

Official title: Phase I Study To Determine The Safety Of Caelyx (Doxorubin HCI, Pegylated Liposomal) In Combination With Ifosfamide In Previously Untreated Adult Patients With Advanced And/Or Metastatic Soft Tissues Sarcomas

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 I trial to study the effectiveness of combining liposomal doxorubicin with ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of ifosfamide in combination with doxorubicin HCl liposome in patients with previously untreated advanced or metastatic soft tissue sarcoma.
  • Determine the objective response in patients treated with this regimen.
  • Determine the dose-limiting toxicity in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of ifosfamide.

Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and ifosfamide IV over 4 hours on days 1-3 OR on days 1-4 (for patients enrolled on dose level 6). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ifosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

Conditions
Sarcoma
Being tested
ifosfamide, pegylated liposomal doxorubicin hydrochloride
Keywords
adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, stage III adult soft tissue sarcoma, adult alveolar soft-part sarcoma, adult epithelioid sarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, adult malignant mesenchymoma, adult rhabdomyosarcoma, stage IV adult soft tissue sarcoma
Medical subject headings
Sarcoma, Hemangiosarcoma, Fibrosarcoma, Leiomyosarcoma, Liposarcoma, Neurofibrosarcoma, Sarcoma, Synovial, Sarcoma, Alveolar Soft Part

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ifosfamideDrug

  • pegylated liposomal doxorubicin hydrochlorideDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 2001
  3. Primary completionMar 2005

Resources

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 1
Primary purpose
Treatment
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030784
Sponsor's protocol ID
EORTC-62002
Other IDs
EORTC-62002
Status last verified
Sep 2012
First submitted
14 Feb 2002
Last updated
24 Sep 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ifosfamide and pegylated liposomal doxorubicin hydrochloride in people with Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 2 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: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark, Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 NCT00030784.

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 24 Sep 2012; AzTrials last refreshed its copy on 7 Nov 2026.

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