Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

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

Sponsors

Lead Sponsor: Daiichi Sankyo, Inc.

Collaborator: National Cancer Institute (NCI)

Source Daiichi Sankyo, Inc.
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.

Overall Status Completed
Start Date 2003-04-01
Completion Date 2005-12-01
Primary Completion Date 2005-12-01
Phase Phase 2
Study Type Interventional
Condition
Intervention

Intervention Type: Drug

Intervention Name: soblidotin

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

Gender:

All

Minimum Age:

15 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Juan Pagan Study Chair Daiichi Sankyo, Inc.
Location
Facility:
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama, 35294-3300, United States
Indiana University Cancer Center | Indianapolis, Indiana, 46202-5289, United States
Memorial Sloan-Kettering Cancer Center | New York, New York, 10021, United States
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York, 10032, United States
University of Texas - MD Anderson Cancer Center | Houston, Texas, 77030-4009, United States
Veterans Affairs Medical Center - San Juan | San Juan, 00927-5800, Puerto Rico
Location Countries

Puerto Rico

United States

Verification Date

2012-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary Purpose: Treatment

Masking: None (Open Label)

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