Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003718
First received: November 1, 1999
Last updated: January 3, 2014
Last verified: August 2001

November 1, 1999
January 3, 2014
September 1998
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Complete list of historical versions of study NCT00003718 on ClinicalTrials.gov Archive Site
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Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
Phase II Evaluation of Temodal (Temozolomide, Schering) in Previously Treated Advanced Sarcomas

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Endometrial Cancer
  • Ovarian Cancer
  • Sarcoma
Drug: temozolomide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
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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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003718
CDR0000066827, CPMC-IRB-8358, NCI-V98-1510
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Herbert Irving Comprehensive Cancer Center
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Study Chair: Robert N. Taub, MD, PhD Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
August 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP