NCT00003718

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

April 14, 2004

Completed
Last Updated

January 6, 2014

Status Verified

August 1, 2001

First QC Date

November 1, 1999

Last Update Submit

January 3, 2014

Conditions

Endometrial CancerOvarian CancerSarcoma

Keywords

adult angiosarcomaadult fibrosarcomaadult leiomyosarcomaadult liposarcomaadult neurofibrosarcomaadult synovial sarcomarecurrent adult soft tissue sarcomaadult extraskeletal chondrosarcomaadult alveolar soft-part sarcomaadult epithelioid sarcomaadult malignant fibrous histiocytomaadult malignant hemangiopericytomaadult malignant mesenchymomaadult rhabdomyosarcomastage IV uterine sarcomarecurrent uterine sarcomauterine carcinosarcomauterine leiomyosarcomaendometrial stromal sarcomaovarian sarcomastage IV adult soft tissue sarcoma

Interventions

temozolomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically, cytologically, or clinically confirmed unresectable, stage IV, or recurrent soft tissue sarcoma No Ewing's sarcoma, Kaposi's sarcoma, bone sarcomas, mesotheliomas, or primitive neuroectodermal tumors Bidimensionally measurable disease by x-ray, CT scan or MRI, or physical examination No CNS metastases No more than 2 prior chemotherapy regimens for advanced, recurrent, or metastatic disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin greater than 10.0 g/dL WBC at least 3,500/mm3 OR Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 1.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: Calcium less than ULN Creatinine or BUN less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or fully excised and/or treated stage I cancer currently in complete remission No nonmalignant systemic disease rendering patient a poor medical risk No acute infection requiring IV antibiotics HIV negative No AIDS-related illness No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction) PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic response modifier treatment allowed At least 4 weeks since prior immunotherapy At least 4 weeks since prior biologic therapy No concurrent epoetin alfa Chemotherapy: See Disease Characteristics Prior dacarbazine allowed At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy for malignancy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to areas of measurable disease unless there is clear progression or there is measurable disease outside the area of prior radiation No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered 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

Study Sites (1)

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Endometrial NeoplasmsOvarian NeoplasmsSarcomaHemangiosarcomaFibrosarcomaLeiomyosarcomaLiposarcomaNeurofibrosarcomaSarcoma, SynovialChondrosarcoma, Extraskeletal MyxoidSarcoma, Alveolar Soft PartHistiocytoma, Malignant FibrousHemangiopericytoma, MalignantMalignant mesenchymal tumorRhabdomyosarcomaSarcoma, Endometrial Stromal

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms, Vascular TissueNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Muscle TissueNeoplasms, Adipose TissueNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissuePeripheral Nervous System NeoplasmsNervous System NeoplasmsNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesHistiocytomaMyosarcomaNeoplasms, Complex and MixedEndometrial Stromal Tumors

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Robert N. Taub, MD, PhD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 14, 2004

Study Start

September 1, 1998

Last Updated

January 6, 2014

Record last verified: 2001-08

Locations

US(1)