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Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
soblidotin
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring 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

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Indiana University Cancer Center
  • Memorial Sloan-Kettering Cancer Center
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • University of Texas - MD Anderson Cancer Center
  • Veterans Affairs Medical Center - San Juan

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2003
Last Updated
May 15, 2012
Sponsor
Daiichi Sankyo, Inc.
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00064220
Brief Title
Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
soblidotin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Pagan
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Veterans Affairs Medical Center - San Juan
City
San Juan
ZIP/Postal Code
00927-5800
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
17109446
Citation
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. doi: 10.1002/cncr.22334.
Results Reference
result

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Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

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