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A Phase II Study of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, to Patients With Advanced or Metastatic Soft Tissue Sarcomas (STS) With Prior Exposure to Anthracycline-Based Chemotherapy


Phase 2
15 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

A Phase II Study of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, to Patients With Advanced or Metastatic Soft Tissue Sarcomas (STS) With Prior Exposure to Anthracycline-Based Chemotherapy


OBJECTIVES:

- Determine the objective tumor response rate in patients with advanced or metastatic
soft tissue sarcoma with prior exposure to anthracycline-based chemotherapy when
treated with soblidotin.

- Determine the duration of response in patients treated with this drug.

- Determine the time to tumor progression in patients treated with this drug.

- Determine the median survival time and 12-month survival rate of patients treated with
this drug.

- Determine the quantitative and qualitative toxic effects of this drug in these
patients.

- Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive soblidotin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks
for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed soft tissue sarcoma of 1 of the following tumor types:

- Malignant fibrous histiocytoma

- Liposarcoma

- Rhabdomyosarcoma

- Synovial sarcoma

- Malignant paraganglioma

- Fibrosarcoma

- Leiomyosarcoma

- Angiosarcoma, including hemangiopericytoma

- Malignant peripheral nerve sheath tumor

- Unclassified sarcoma

- Miscellaneous sarcoma, including mixed mesodermal tumors of the uterus

- The following tumor types are not eligible:

- Gastrointestinal stromal tumor

- Chondrosarcoma

- Malignant mesothelioma

- Neuroblastoma

- Osteosarcoma

- Ewing's sarcoma

- Embryonal rhabdomyosarcoma

- Evidence of disease progression

- Must have received 1 prior anthracycline-based chemotherapy regimen for metastatic
disease

- Adjuvant chemotherapy is not considered 1 prior regimen unless tumor progressed
within 12 months of therapy

- At least 1 measurable lesion with indicator lesions outside of any prior radiation
field

- No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

- 15 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN
if liver metastases are present)

- Bilirubin no greater than 1.5 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

Cardiovascular

- Ejection fraction at least 40% by MUGA

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No baseline neurotoxicity grade 2 or greater

- No concurrent serious infection

- No psychiatric disorder that would preclude giving informed consent or complying with
study requirements

- No other concurrent severe or uncontrolled medical illness that would preclude study
participation

- No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix,
or any other malignancy for which the patient has been in complete remission and off
all therapy for at least 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent anticancer biologic therapy

Chemotherapy

- See Disease Characteristics

- More than 4 weeks since prior chemotherapy and recovered

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- Recovered from prior radiotherapy

- No concurrent radiotherapy

- Localized radiotherapy to a non-indicator lesion for pain relief allowed
provided all other methods of pain control are ineffective

Surgery

- At least 4 weeks since prior major surgery and recovered

Other

- At least 4 weeks since prior myelosuppressive therapy

- At least 4 weeks since prior investigational drugs

- No other concurrent investigational drugs

- No other concurrent anticancer cytotoxic therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Juan Pagan

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000310138

NCT ID:

NCT00064220

Start Date:

April 2003

Completion Date:

December 2005

Related Keywords:

  • Sarcoma
  • adult leiomyosarcoma
  • adult malignant fibrous histiocytoma
  • adult liposarcoma
  • adult rhabdomyosarcoma
  • adult synovial sarcoma
  • adult fibrosarcoma
  • adult angiosarcoma
  • adult malignant hemangiopericytoma
  • stage IV adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032