Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064220
• Other study ID #: CDR0000310138
• Secondary ID: DAIICHI-1027A-PR
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2003
• Last updated: May 15, 2012
• Start date: April 2003
• Est. completion date: December 2005

Study information

• Verified date: May 2012
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• soblidotin

Locations

Country	Name	City	State
Puerto Rico	Veterans Affairs Medical Center - San Juan	San Juan
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

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 — View Citation