ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma

This study is ongoing, but not recruiting participants.

Sponsored by: Herbert Irving Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003718
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Ovarian Cancer
Sarcoma
Drug: temozolomide
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer    Soft Tissue Sarcoma   

ChemIDplus related topics:   Temozolomide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Evaluation of Temodal (Temozolomide, Schering) in Previously Treated Advanced Sarcomas

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   25
Study Start Date:   September 1998

Detailed Description:

OBJECTIVES: I. Determine the efficacy, as measured by the response rate, of temozolomide in patients with unresectable, stage IV, or recurrent soft tissue sarcoma who have failed no more than 2 prior treatment regimens. II. Determine the clinical and laboratory toxicities, as well as patient tolerance, of this regimen in this patient population.

OUTLINE: Patients are stratified according to ECOG performance status (0-1 vs 2), prior surgery (yes vs no), prior radiotherapy (yes vs no), and prior chemotherapy regimens (0 vs 1 vs 2). Patients receive oral temozolomide every 12 hours for 5 days. Courses repeat every 4 weeks for at least 18 months in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first 18 months, every 6 months for the next 18 months, and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003718

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center    
      New York, New York, United States, 10032

Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center

Investigators
Study Chair:     Robert N. Taub, MD, PhD     Herbert Irving Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066827, CPMC-IRB-8358, NCI-V98-1510
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003718
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult angiosarcoma  
adult fibrosarcoma  
adult leiomyosarcoma  
adult liposarcoma  
adult neurofibrosarcoma  
adult synovial sarcoma  
recurrent adult soft tissue sarcoma  
adult extraskeletal chondrosarcoma  
adult alveolar soft-part sarcoma  
adult epithelioid sarcoma  
adult malignant fibrous histiocytoma  
adult malignant hemangiopericytoma
adult malignant mesenchymoma
adult rhabdomyosarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
uterine carcinosarcoma
uterine leiomyosarcoma
endometrial stromal sarcoma
ovarian sarcoma
stage IV adult soft tissue sarcoma

Study placed in the following topic categories:
Histiocytoma, Malignant Fibrous
Fibrosarcoma
Sarcoma, Endometrial Stromal
Histiocytoma, Benign Fibrous
Leiomyosarcoma
Gonadal Disorders
Epithelioid sarcoma
Malignant mesenchymal tumor
Alveolar soft part sarcoma
Urogenital Neoplasms
Ovarian Diseases
Soft tissue sarcomas
Sarcoma, Synovial
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Endometrial Neoplasms
Chondrosarcoma
Uterine Neoplasms
Sarcoma, Alveolar Soft Part
Endometrial cancer
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Ovarian cancer
Ovarian Neoplasms
Endometrial stromal sarcoma
Synovial sarcoma
Genital Neoplasms, Female
Uterine Diseases
Endocrine System Diseases
Hemangiosarcoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on October 15, 2008




Links to all studies - primarily for crawlers