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Docetaxel and Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors

2014-08-27 03:41:59 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with erlotinib may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with docetaxel in treating patients with solid tumors and to see how well they work in treating patients with advanced non-small cell lung cancer. (Phase I portion of the study treating patients with any solid tumor was completed as of 12/01/2004)

Description

OBJECTIVES:

Primary

- Determine the safety and feasibility of two different schedules of erlotinib hydrochloride and docetaxel in patients with advanced solid tumors. (Phase I [completed as of 12/01/2004])

- Determine the response rate in patients with advanced non-small cell lung cancer treated with second-line docetaxel and erlotinib hydrochloride. (Phase II)

Secondary

- Compare the toxicity of two different schedules of erlotinib hydrochloride and docetaxel in these patients. (Phase I [completed as of 12/01/2004])

- Determine the maximum tolerated dose of two different schedules of erlotinib hydrochloride and docetaxel. (Phase I [completed as of 12/01/2004])

- Assess the overall survival and progression-free survival. (Phase II)

- Determine the frequency and severity of toxicities associated with this treatment regimen. (Phase II)

Tertiary

- Perform laboratory correlative studies on patient tissue and blood samples to investigate potential predictors of response.

OUTLINE: This is a phase I, dose-escalation study of erlotinib hydrochloride (phase I completed as of 12/01/2004) followed by a phase II, open-label study.

- Phase I (completed as of 12/01/2004): Patients will be assigned in alternating fashion to 1 of 2 treatment groups.

- Group I: Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16.

- Group II: Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16.

In both groups, treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.

In both groups, cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride 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.

- Phase II: Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.

Blood samples, buccal mucosal cells, and tumor tissue are obtained before and after treatment. Epidermal growth factor receptor (EGFR) expression and polymorphisms and p27 protein expression are assessed by immunohistochemistry. Immunofluorescence (by laser-scanning cytometry) is used to detect EGFR and p27.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

docetaxel, erlotinib hydrochloride

Location

University of California Davis Cancer Center
Sacramento
California
United States
95817

Status

Active, not recruiting

Source

University of California, Davis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:59-0400

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Medical and Biotech [MESH] Definitions

A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.

Tumors or cancer of the LUNG.

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

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.

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