NCT00003939

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have advanced soft tissue sarcoma.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

June 3, 2004

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

First QC Date

November 1, 1999

Last Update Submit

September 20, 2012

Conditions

Brain and Central Nervous System TumorsEndometrial CancerGastrointestinal Stromal TumorOvarian CancerSarcomaSmall Intestine Cancer

Keywords

adult angiosarcomaadult fibrosarcomaadult leiomyosarcomaadult liposarcomaadult neurofibrosarcomaadult synovial sarcomastage IV adult soft tissue sarcomarecurrent adult soft tissue sarcomasmall intestine leiomyosarcomaadult alveolar soft-part sarcomaadult epithelioid sarcomaadult malignant fibrous histiocytomaadult malignant hemangiopericytomaadult malignant mesenchymomaadult rhabdomyosarcomastage IV uterine sarcomarecurrent uterine sarcomauterine carcinosarcomauterine leiomyosarcomaendometrial stromal sarcomaovarian sarcomaadult meningeal hemangiopericytomagastrointestinal stromal tumor

Interventions

trabectedinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven soft tissue sarcoma, including the following cell types: Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma including hemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Miscellaneous sarcoma including mixed mesodermal tumors of the uterus Cell types NOT allowed: Malignant mesothelioma Chondrosarcoma Neuroblastoma Osteosarcoma Ewing's sarcoma Embryonal rhabdomyosarcoma Measurable lesion with evidence of progression within 6 weeks prior to study (osseous lesions, hepatomegaly, lymphedema, ascites, and pleural lesions are not considered measurable) No symptomatic or known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.75 mg/dL Albumin at least 2.5 g/dL AST and ALT less than 1.5 times upper limit of normal (ULN) (2.5 times ULN if liver metastasis present) Alkaline phosphatase less than 2.5 times ULN No other significant hepatic disease (e.g., active hepatitis, cirrhosis, etc.) Renal: Creatinine no greater than 1.36 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No prior cardiovascular disease Other: No other severe medical illness No psychosis No prior or concurrent second primary malignant tumors, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy No more than 1 prior regimen of combination chemotherapy OR No more than 2 prior single agent regimens No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to sole index lesion No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (4)

  • Therasse P, Le Cesne A, Van Glabbeke M, Verweij J, Judson I; EORTC Soft Tissue and Bone Sarcoma Group. RECIST vs. WHO: prospective comparison of response criteria in an EORTC phase II clinical trial investigating ET-743 in advanced soft tissue sarcoma. Eur J Cancer. 2005 Jul;41(10):1426-30. doi: 10.1016/j.ejca.2005.04.005.

    PMID: 15919202BACKGROUND

  • Le Cesne A, Blay JY, Judson I, Van Oosterom A, Verweij J, Radford J, Lorigan P, Rodenhuis S, Ray-Coquard I, Bonvalot S, Collin F, Jimeno J, Di Paola E, Van Glabbeke M, Nielsen OS. Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group trial. J Clin Oncol. 2005 Jan 20;23(3):576-84. doi: 10.1200/JCO.2005.01.180.

    PMID: 15659504RESULT

  • Blay JY, Le Cesne A, Verweij J, Scurr M, Seynaeve C, Bonvalot S, Hogendoorn P, Jimeno J, Evrard V, van Glabbeke M, Judson I. A phase II study of ET-743/trabectedin ('Yondelis') for patients with advanced gastrointestinal stromal tumours. Eur J Cancer. 2004 Jun;40(9):1327-31. doi: 10.1016/j.ejca.2004.02.005.

    PMID: 15177491RESULT

  • Le Cesne A, Judson I, Blay JY, et al.: Phase II study of ET-743 in advanced soft tissue sarcoma (ASTS) in adults: a STBSG-EORTC trial. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A-2182, 2000.

    RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsEndometrial NeoplasmsGastrointestinal Stromal TumorsOvarian NeoplasmsSarcomaHemangiosarcomaFibrosarcomaLeiomyosarcomaLiposarcomaNeurofibrosarcomaSarcoma, SynovialSarcoma, Alveolar Soft PartHistiocytoma, Malignant FibrousHemangiopericytoma, MalignantMalignant mesenchymal tumorRhabdomyosarcomaSarcoma, Endometrial Stromal

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Vascular TissueNeoplasms, Fibrous TissueNeoplasms, Muscle TissueNeoplasms, Adipose TissueNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissuePeripheral Nervous System NeoplasmsPeripheral Nervous System DiseasesNeuromuscular DiseasesHistiocytomaMyosarcomaNeoplasms, Complex and MixedEndometrial Stromal Tumors

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Axel Le Cesne, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 3, 2004

Primary Completion

November 1, 2000

Last Updated

September 24, 2012

Record last verified: 2012-09