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Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Undifferentiated Pleomorphic Sarcoma

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Antineoplastic Agents

All Drugs and Chemicals

Soblidotin

soblidotin

Juan Pagan

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.

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.

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

National Cancer Institute (NCI)

Daiichi Sankyo

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Peter Cheverton, MD, ChB, MMED, RadT

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 progressive locally advanced or metastatic non-small cell lung cancer.

OBJECTIVES:

* Determine the objective tumor response rate and duration of response in patients with progressive locally advanced or metastatic non-small cell lung cancer treated with soblidotin as second-line therapy after receiving prior platinum-based chemotherapy.
* 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. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Plasma sampling for pharmacokinetics is done on day 1 of course 1.

Patients are followed for survival every 3 months after discontinuing study treatment.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 1 year.

Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase II Study Of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, To Patients With Progressive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) Following Treatment With Platinum-Based Chemotherapy

Gemcitabine

Antimetabolites

gemcitabine

chemotherapy

Robert L. DeJager, MD, FACP

RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of soblidotin and gemcitabine in treating patients with locally advanced or metastatic solid tumors.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with locally advanced or metastatic solid tumors.
* Determine the dose-limiting toxic effects of this regimen in these patients.

Secondary

* Determine the toxicity profile of this regimen in these patients.
* Determine the pharmacokinetics of this regimen in these patients.
* Determine, preliminarily, the antitumor activity of this regimen in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study.

Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed for survival every 3 months after completion of study therapy.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 1 year.

Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors

Daiichi Pharmaceuticals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma	NCT00064220	Sarcoma	soblidotin	15 Years -	Daiichi Sankyo
Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer	NCT00061854	Lung Cancer	soblidotin	18 Years -	Daiichi Sankyo
Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors	NCT00072228	Unspecified Adu...	gemcitabine soblidotin chemotherapy	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for soblidotin

Every month we try and update this database with for soblidotin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for soblidotin

Every month we try and update this database with for soblidotin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for soblidotin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.