Gemcitabine & Oxaliplatin as Second-Line Therapy in Treating Patients With

Status Completed

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.

Clinical Trial Description

OBJECTIVES:

Primary

- Determine the efficacy and safety of gemcitabine hydrochloride and oxaliplatin as second-line chemotherapy in patients with stage IIIB or IV non-small cell lung cancer.

- Determine overall response in patients treated with this regimen.

Secondary

- Determine time to progression, time to treatment failure, and overall survival of these patients.

- Determine the type, frequency, severity, timing, and relatedness of all adverse events during treatment and for 30 days after completion of study treatment.

- Assess the quality of life of these patients.

- Determine the expression of RRM1 and ERCC1 in peripheral blood mononuclear cells from these patients.

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

Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at the beginning of each course, at the completion of study treatment, and then every 6 weeks thereafter.

After completion of study treatment, patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00305786
Study type	Interventional
Source	University of Miami
Contact
Status	Completed
Phase	Phase 2
Start date	August 2005
Completion date	May 2010

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms