Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00064220
First received: July 8, 2003
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma.


Condition Intervention Phase
Sarcoma
Drug: soblidotin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Study Start Date: April 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064220

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan, Puerto Rico, 00927-5800
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Study Chair: Juan Pagan Daiichi Sankyo Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00064220     History of Changes
Other Study ID Numbers: CDR0000310138, DAIICHI-1027A-PRT007, CPMC-IRB-20030512, MSKCC-03061
Study First Received: July 8, 2003
Last Updated: May 15, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
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

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Soblidotin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014