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SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

2014-08-27 03:56:19 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SGN-15 may be able to locate tumor cells and kill them without harming normal cells. Combining SGN-15 with docetaxel may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of metastatic or recurrent non-small cell lung cancer.

Description

OBJECTIVES:

- Determine the toxicity and safety profile of SGN-15 (cBR96-doxorubicin immunoconjugate) in combination with docetaxel in patients with advanced or recurrent non-small cell lung carcinoma.

- Determine the clinical response rate and response duration in patients treated with this regimen.

- Determine the progression-free survival and overall survival of patients treated with this regimen.

OUTLINE: This is a randomized, open-label study. Patients are stratified according to gender and performance status. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive SGN-15 (cBR96-doxorubicin immunoconjugate) IV over 2 hours followed by docetaxel IV over 30 minutes once weekly on weeks 1-3 and 5-7.

- Arm II: Patients receive docetaxel as in arm I. Quality of life is assessed at baseline and on day 1 of each course.

Patients are followed at 8 weeks.

PROJECTED ACCRUAL: A total of 60 patients (40 in arm I and 20 in arm II) will be accrued for this study within 18-24 months.

Study Design

Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

cBR96-doxorubicin immunoconjugate, docetaxel

Location

Cancer Institute at Oregon Health and Science University
Portland
Oregon
United States
97239-3098

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:19-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the LUNG.

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.

Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.

A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.

A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).

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