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Phase II Evaluation of Temodal (Temozolomide, Schering) in Previously Treated Advanced Sarcomas

Phase 2
18 Years
Open (Enrolling)
Endometrial Cancer, Ovarian Cancer, Sarcoma

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Trial Information

Phase II Evaluation of Temodal (Temozolomide, Schering) in Previously Treated Advanced Sarcomas

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.

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert N. Taub, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Ovarian Cancer
  • Sarcoma
  • 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
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Adenoma
  • Sarcoma



Herbert Irving Comprehensive Cancer Center New York, New York  10032