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Dose Finding and Phase II Study of STI 571 in Advanced Soft Tissue Sarcoma


Phase 1/Phase 2
15 Years
N/A
Not Enrolling
Both
Endometrial Cancer, Gastrointestinal Stromal Tumor, Ovarian Cancer, Sarcoma, Small Intestine Cancer

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Trial Information

Dose Finding and Phase II Study of STI 571 in Advanced Soft Tissue Sarcoma


OBJECTIVES: I. Determine the maximum tolerated dose and associated toxicity of STI571 in
patients with refractory or recurrent soft tissue sarcoma. II. Determine the pharmacokinetic
profile of this treatment regimen in these patients. III. Determine the objective response
and duration of response in these patients with this treatment regimen.

OUTLINE: This is a dose escalation and dose efficacy, multicenter study. In the dose
efficacy portion, patients are stratified according to disease type (gastrointestinal
stromal tumor vs all other soft tissue sarcomas). Phase I: Patients receive oral STI571
daily for a maximum of 24 months in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-8 patients receive escalating doses of STI571 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6-8
patients experience dose limiting toxicities. The recommended phase II dose is defined as
the dose preceding the MTD. Phase II: Patients receive the recommended phase II dose of
STI571 as in phase I. Patients are followed every 8 weeks until disease progression, and
then every 16 weeks thereafter.

PROJECTED ACCRUAL: Approximately 47-72 patients (7-32 in phase I and 40 in phase II) will be
accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma Malignant fibrous
histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma
Fibrosarcoma Leiomyosarcoma Angiosarcoma Hemangiopericytoma Neurogenic sarcoma
Unclassified sarcoma Miscellaneous sarcoma (including mixed mesodermal tumors of the
uterus) Gastrointestinal stromal tumor (GIST) (must be c-kit positive) No malignant
mesothelioma, chondrosarcoma, neuroblastoma, osteosarcoma, Ewing's sarcoma, or embryonal
rhabdomyosarcoma Phase I study and nonGIST phase II study patients: Must have received one
prior first line combination chemotherapy regimen or two first line single agent regimens
Adjuvant chemotherapy not considered first line, unless disease progression within 6
months of treatment Phase II GIST patients: No more than one prior first line combination
chemotherapy regimen or two first line single agent regimens Adjuvant chemotherapy not
considered first line, unless disease progression within 6 months of treatment Measurable
disease with evidence of progression in past 6 weeks Osseous lesions and pleural effusions
not considered measurable No symptomatic or known CNS metastases

PATIENT CHARACTERISTICS: Age: 15 and over Performance status: WHO 0-1 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL Albumin at least 25 g/L
Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance greater than 65 mL/min
Cardiovascular: No history of cardiovascular disease Other: No prior or concurrent second
primary malignant tumors except adequately treated carcinoma in situ of the cervix or
basal cell carcinoma No other severe illness (including psychosis) Not pregnant Fertile
patients must use effective contraception during and for 6 months following study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 4 weeks since prior chemotherapy No other concurrent local or
systemic chemotherapy Endocrine therapy: No concurrent systemic corticosteroid therapy
Radiotherapy: No prior radiotherapy to sole index lesion Concurrent radiotherapy to any
lesion allowed if not the sole target lesion Surgery: Not specified Other: No prior
embolization to sole index lesion No other concurrent investigational drug No concurrent
warfarin

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jacob Verweij, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-62001-16003

NCT ID:

NCT00006357

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Gastrointestinal Stromal Tumor
  • Ovarian Cancer
  • Sarcoma
  • Small Intestine Cancer
  • adult angiosarcoma
  • adult fibrosarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • adult neurofibrosarcoma
  • adult synovial sarcoma
  • recurrent adult soft tissue sarcoma
  • small intestine leiomyosarcoma
  • adult alveolar soft-part sarcoma
  • adult epithelioid sarcoma
  • adult malignant fibrous histiocytoma
  • adult malignant hemangiopericytoma
  • adult malignant mesenchymoma
  • adult rhabdomyosarcoma
  • ovarian stromal cancer
  • recurrent uterine sarcoma
  • uterine carcinosarcoma
  • uterine leiomyosarcoma
  • endometrial stromal sarcoma
  • ovarian sarcoma
  • gastrointestinal stromal tumor
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Adenoma
  • Gastrointestinal Stromal Tumors
  • Intestinal Neoplasms
  • Sarcoma

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