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T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy

2014-08-27 03:56:41 | BioPortfolio

Summary

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.

Description

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 Design

Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

T138067 sodium

Location

UCSF Cancer Center and Cancer Research Institute
San Francisco
California
United States
94143-0128

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:41-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the LUNG.

A sodium-hydrogen antiporter expressed primarily by EPITHELIAL CELLS in the kidneys, it localizes to the apical membrane of the PROXIMAL KIDNEY TUBULE, where it functions in sodium and water reabsorption and possibly calcium homeostasis. It also is expressed in heart, brain, and lung tissues and is resistant to AMILORIDE inhibition.

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

An AMILORIDE-sensitive sodium channel found on salt-reabsorbing EPITHELIAL CELLS that line the distal NEPHRON, the distal COLON; SALIVARY DUCTS; SWEAT GLANDS; and the LUNG. It plays a critical role in the control of sodium balance, BLOOD VOLUME, and BLOOD PRESSURE.

Sodium channels found on salt-reabsorbing EPITHELIAL CELLS that line the distal NEPHRON; the distal COLON; SALIVARY DUCTS; SWEAT GLANDS; and the LUNG. They are AMILORIDE-sensitive and play a critical role in the control of sodium balance, BLOOD VOLUME, and BLOOD PRESSURE.

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