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Sponsored by: |
University of Miami Sylvester Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00305786 |
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.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: gemcitabine hydrochloride Drug: oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease |
Estimated Enrollment: | 30 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Failed first-line chemotherapy
Must have received ≥ 1, but no more than 2, prior chemotherapy regimens for stage IIIB or IV NSCLC
At least 1 unidimensionally measurable lesion with diameter ≥ 20 mm by conventional methods OR ≥ 10 mm by spiral CT scan
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
No history of an acute cardiac or CNS event within the past 6 months, including any of the following:
No serious uncontrolled medical or psychiatric illness, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
University of Miami Sylvester Comprehensive Cancer Center - Miami | |
Miami, Florida, United States, 33136 |
Study Chair: | Caio Max S. Rocha Lima, MD | University of Miami Sylvester Comprehensive Cancer Center - Miami |
Responsible Party: | University of Miami Sylvester Comprehensive Cancer Center - Miami ( Caio Max S. Rocha Lima ) |
Study ID Numbers: | CDR0000464698, SCCC-2004078, SCCC-EPROST-20043597, SANOFI-SCCC-2004078, WIRB-20050485, SCCC-1066207 |
Study First Received: | March 21, 2006 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00305786 History of Changes |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Immunologic Factors Immunosuppressive Agents Antiviral Agents Recurrence Carcinoma Oxaliplatin |
Radiation-Sensitizing Agents Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Oxaliplatin Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses |
Gemcitabine Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |