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Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00064220
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : May 16, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE July 8, 2003
First Posted Date  ICMJE July 9, 2003
Last Update Posted Date May 16, 2012
Study Start Date  ICMJE April 2003
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00064220 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
Official Title  ICMJE 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
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE Drug: soblidotin
Study Arms  ICMJE Not Provided
Publications * Patel S, Keohan ML, Saif MW, Rushing D, Baez L, Feit K, DeJager R, Anderson S. Phase II study of intravenous TZT-1027 in patients with advanced or metastatic soft-tissue sarcomas with prior exposure to anthracycline-based chemotherapy. Cancer. 2006 Dec 15;107(12):2881-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00064220
Other Study ID Numbers  ICMJE CDR0000310138
DAIICHI-1027A-PRT007
CPMC-IRB-20030512
MSKCC-03061
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Juan Pagan Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date May 2012

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