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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00057798 |
RATIONALE: Determination of genetic changes in patients with non-small cell lung cancer may help predict the outcome of treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study genetic changes and the effectiveness of combining vinorelbine with gemcitabine before surgery in treating patients who have stage IB, stage II, or stage III non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: gemcitabine hydrochloride Drug: vinorelbine ditartrate Procedure: conventional surgery Procedure: cytogenetic analysis Procedure: gene expression profiling Procedure: loss of heterozygosity analysis Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Observational |
Official Title: | Molecular And Genetic Changes In Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Vinorelbine And Gemcitabine - Phase II Study |
Study Start Date: | March 2000 |
OBJECTIVES:
OUTLINE: Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 30 minutes on days 1, 8, 22, and 29 in the absence of disease progression or unacceptable toxicity.
Patients with no disease progression by scans or bronchoscopy undergo surgical resection between days 57-70 (weeks 8-10).
Loss of heterozygosity (LOH) at loci on chromosomes 3p, 9p, and 11p is assessed in blood specimens, tumor tissue, and noncancerous tissue before and after chemotherapy. Specimens are also examined for molecular markers of occult metastasis using reverse transcriptase-polymerase chain reaction. Multidrug resistance-associated protein gene expression is also determined using microarray technology.
Patients are followed every 3 months for 2 years, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell carcinoma of the lung
No metastatic disease (except N1 or N2 disease) or malignant pleural effusion* detected on preoperative evaluation
No exudative effusions (even if cytologically negative)
Pleural fluid is considered exudative if the following apply:
NOTE: **If only 1 area shows an increase in FDG uptake, the area of concern requires further evaluation (e.g., biopsy) to exclude metastatic disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Study Chair: | Nithya Ramnath, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000270753, RPCI-RP-00-01 |
Study First Received: | April 7, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00057798 |
Health Authority: | United States: Federal Government |
stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Vinorelbine Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Vinblastine Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors |
Antimitotic Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |