T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy
|ClinicalTrials.gov Identifier: NCT00022243|
Recruitment Status : Unknown
Verified May 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 4, 2004
Last Update Posted : January 6, 2014
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of T138067 in treating patients who have locally advanced or metastatic non-small cell lung cancer that has not responded to previous chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: batabulin sodium||Phase 2|
OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced or metastatic non-small cell lung cancer who have failed first-line therapy with a taxane when treated with T138067 sodium. II. Determine the qualitative and quantitative toxic effects of this drug in these patients. III. Determine the number of patients who progress when treated with this drug. IV. Determine the duration of response, time to disease progression, and median survival of patients treated with this drug. V. Correlate the toxic effects of this drug with peak plasma levels in this patient population.
OUTLINE: This is a multicenter study. Patients receive T138067 sodium IV over 3 hours on days 1, 8, and 15. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months after study completion.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 9 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II, Open Label Study Of T138067-Sodium In A Second-Line Setting In Non-Small-Cell Lung Cancer Patients With Locally Advanced Or Metastatic Disease Who Have Failed First-Line Therapy With a Taxane|
|Study Start Date :||October 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022243
|United States, California|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94143-0128|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Study Chair:||Sean McCarthy||Tularik|