Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00064220

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: soblidotin	Phase 2

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 Design

Study Type:

Interventional

Masking:

None (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

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
2	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
3	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
4	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York	United States	10032
5	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
6	Veterans Affairs Medical Center - San Juan	San Juan		Puerto Rico	00927-5800