Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00002904
Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors
A Phase 1 study testing trabectedin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by European Organisation for Research and Treatment of Cancer - EORTC at 49 sites in 14 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 I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- trabectedin
- How many people
- 40 participants
- Where
- 49 sitesin 14 countries
- Study dates
- Feb 1996to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor that is not amenable to standard therapy No evidence of brain involvement or leptomeningeal disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: ANC at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 mg/dL Transaminases normal (no greater than 2.5 times normal if liver metastases) Alkaline phosphatase normal (no greater than 2.5 times normal if liver or bone metastases) No history of chronic liver disease, e.g., chronic active hepatitis, cirrhosis Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60 mL/min Other: No active bacterial infection (e.g., abscess) or with fistulae No grade 2 or worse neurotoxicity No concurrent medical condition that precludes treatment No history of alcoholism, drug addiction, or psychotic disorder Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Colony-stimulating factors allowed for specific indications At least 4 weeks since prior biologic therapy, immunotherapy, or growth factors Chemotherapy: No prior intensive chemotherapy with bone marrow or stem cell support At least 4 weeks since chemotherapy (6 weeks since nitrosoureas, mitomycin, or high-dose carboplatin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Concomitant palliative local radiotherapy allowed for existing lesion Surgery: Recovered from prior surgery Other: No concurrent investigational drug Concurrent prophylactic antiemetics allowed after first therapy course
Trial locations and contacts
49 sites in 14 countries.
49 sites in 14 countries
France14 sites
Institut Bergonie
Bordeaux, 33076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Georges-Francois Leclerc
Dijon, 21034
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 69373
CHU de la Timone
Marseille, 13385
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, 44805
Institut Curie - Section Medicale
Paris, 75248
Centre Eugene Marquis
Rennes, 35062
Centre Henri Becquerel
Rouen, 76038
Institut Claudius Regaud
Toulouse, 31052
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Hopital Paul Brousse
Villejuif, 94804
Institut Gustave Roussy
Villejuif, F-94805
Italy5 sites
Centro di Riferimento Oncologico - Aviano
Aviano, 33081
Istituto Europeo Di Oncologia
Milan, 20141
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples (Napoli), 80131
San Raffaele Hospital
Rome, 00144
Istituti Fisioterapici Ospitalieri - Roma
Rome, 00161
Netherlands5 sites
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, 1007 MB
Antoni van Leeuwenhoekhuis
Amsterdam, 1066 CX
Academisch Ziekenhuis Groningen
Groningen, 9713 EZ
St. Radboud University Hospital
Nijmegen, 6500 HB
Rotterdam Cancer Institute
Rotterdam, 3075 EA
Switzerland5 sites
University Hospital
Basel, CH-4031
Ospedale San Giovanni
Bellinzona, CH-6500
Inselspital, Bern
Bern, CH-3010
Clinique De Genolier
Genolier, Ch-1272
Kantonsspital - Saint Gallen
Sankt Gallen, CH-9007
Germany4 sites
Martin Luther Universitaet
Halle, DOH-0-6112
Universitats-Krankenhaus Eppendorf
Hamburg, D-20246
Medizinische Hochschule Hannover
Hanover, D-30625
Klinikum Nurnberg
Nuremberg (Nurnberg), D-90419
United Kingdom4 sites
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
Royal Marsden NHS Trust
London, England, SW3 6JJ
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Belgium3 sites
Institut Jules Bordet
Brussels (Bruxelles), 1000
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
U.Z. Gasthuisberg
Leuven, B-3000
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Herlev Hospital - University Hospital of Copenhagen
Herlev, DK-2730
Israel2 sites
Rambam Medical Center
Haifa, 31096
Schneider Children's Medical Center of Israel
Petah Tikva, 49202
Austria1 site
Ludwig Boltzmann - Institute for Applied Cancer Research
Vienna (Wien), A-1100
Portugal1 site
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, 1093
About this study
Official title: PHASE I CLINICAL AND PHARMACOKINETIC STUDY TO DETERMINE THE SAFETY OF ECTEINASCIDIN-743 (ET-743) ADMINISTERED AS A SINGLE INTRAVENOUS INFUSION OVER 60 MINUTES EVERY 21 DAYS IN PATIENTS WITH SOLID TUMORS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors.
Read the detailed description
OBJECTIVES: I. Estimate the maximum tolerated dose (MTD) of ecteinascidin-743 (ET-743) when administered as a single intravenous infusion every 21 days in adults with solid tumors not amenable to standard therapy. II. Describe the qualitative and quantitative toxic effects of ET-743, and study the predictability, duration, intensity, onset, reversibility, and dose-relationship of these toxic effects in these patients. III. Propose a safe dose for a phase II study based on the MTD determined on this study. IV. Assess the pharmacokinetics of ET-743 at different dose levels. V. Document any antitumor effects of ET-743 in these patients.
OUTLINE: This is a multicenter study. All patients receive ET-743 IV over 3 hours every 21 days for 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ET-743 until the maximum tolerated dose is determined. Patients are followed at 1 month, then every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 12 months.
- Being tested
- trabectedin
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabectedinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2004 (estimated)
- Study startFeb 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Chris Twelves, MD, BMedSci, FRCP, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002904
- Sponsor's protocol ID
- EORTC-16951
- Other IDs
- EORTC-16951
- Status last verified
- Jun 2012
- First submitted
- 1 Nov 1999
- Last updated
- 2 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE I CLINICAL AND PHARMACOKINETIC STUDY TO DETERMINE THE SAFETY OF ECTEINASCIDIN-743 (ET-743) ADMINISTERED AS A SINGLE INTRAVENOUS INFUSION OVER 60 MINUTES EVERY 21 DAYS IN PATIENTS WITH SOLID TUMORS
- ClinicalTrials.gov ID
- NCT00002904
- Acronym / sponsor ID
- EORTC-16951
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Feb 1996
- First posted
- 3 Sep 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 I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors.
Detailed description
OBJECTIVES: I. Estimate the maximum tolerated dose (MTD) of ecteinascidin-743 (ET-743) when administered as a single intravenous infusion every 21 days in adults with solid tumors not amenable to standard therapy. II. Describe the qualitative and quantitative toxic effects of ET-743, and study the predictability, duration, intensity, onset, reversibility, and dose-relationship of these toxic effects in these patients. III. Propose a safe dose for a phase II study based on the MTD determined on this study. IV. Assess the pharmacokinetics of ET-743 at different dose levels. V. Document any antitumor effects of ET-743 in these patients.
OUTLINE: This is a multicenter study. All patients receive ET-743 IV over 3 hours every 21 days for 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ET-743 until the maximum tolerated dose is determined. Patients are followed at 1 month, then every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 12 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| trabectedin | 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 2 Jul 2012.
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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.
Chris Twelves, MD, BMedSci, FRCP study chair
University of Glasgow
49 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing trabectedin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by European Organisation for Research and Treatment of Cancer - EORTC at 49 sites in 14 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 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in France, Italy, Netherlands, Switzerland, Germany and 9 more countries. 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?
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 2 Jul 2012.