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- Klinische proef NCT00057798
Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery
Molecular And Genetic Changes In Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Vinorelbine And Gemcitabine - Phase II Study
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
OBJECTIVES:
- Determine the frequency of expression of epithelial markers CK19, CK20, MUC1, and MUC5 (by reverse transcriptase-polymerase chain reaction) in lymph node tissue and blood samples of patients with resectable stage IB-III non-small cell lung cancer treated with neoadjuvant vinorelbine and gemcitabine followed by surgery.
- Determine the expression of the multidrug resistance-associated protein gene before and after treatment with this regimen in these patients.
- Determine the global expression profile of genes (by microarray technology) in tumor tissue of patients treated with this regimen.
- Determine the frequency of loss of heterozygosity at several loci on chromosomes 3p, 9p, and 11p before and after treatment with this regimen in these patients.
- Determine the percent positivity of cells that stain for MCM2 and CDC6 (prereplicative complex) by immunohistochemistry before and after treatment with this regimen in these patients.
- Determine the feasibility of this regimen in these patients.
- Determine the pathological response rates in patients treated with this regimen.
- Determine the side effects of this regimen in these patients.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the autologous immune response in patients treated with this regimen.
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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New York
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Buffalo, New York, Verenigde Staten, 14263-0001
- Roswell Park Cancer Institute
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell carcinoma of the lung
- May be confirmed at the initial bronchoscopy and mediastinoscopy
- Stage IB (T2, N0, M0)
- Stage IIA (T1, N1, M0)
- Stage IIB (T2-3, N0-1, M0)
- Stage IIIA (T1-3, N1-2, M0)
- stage IIIB (2 lesions in 1 lobe [T4])
- No N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scaline) OR T4 primary tumor (malignant pleural effusion or mediastinal invasion) by clinical staging criteria (seen on CT or PET scan and proven by mediastinoscopy)
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:
- Ratio of pleural fluid protein to serum protein is greater than 0.5
- Ratio of pleural fluid lactic dehydrogenase (LDH) to serum LDH is at least 0.6
- Pleural fluid LDH is greater than 200 IU/L
- No multiple areas of fluorodeoxyglucose (FDG) uptake** outside the area of the primary tumor in the lung NOTE: *Effusions visible only on CT scan and not large enough for safe thoracentesis are allowed
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
- Bidimensionally measurable or evaluable disease* NOTE: *Lesions apparent on chest CT scan (e.g., ill-defined masses associated with post obstructive changes and mediastinal or hilar adenopathy measurable in 1 dimension) are considered evaluable
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- AST or ALT no greater than 1.5 times upper limit of normal
Renal
- Creatinine no greater than 1.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Deemed medically fit for surgical resection
- No other active malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No psychological, sociological, or geographical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Concurrent participation in the RPCI vaccine study (postoperative vaccination with autologous tumor-associated antigen-pulsed dendritic cells) is allowed
Chemotherapy
- No prior chemotherapy for lung cancer
- No concurrent participation in another study involving other chemotherapy agents
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for lung cancer
- No concurrent participation in another study involving radiotherapy
Surgery
- No prior surgery for lung cancer
- More than 3 months since other prior major surgery (e.g., coronary artery bypass graft)
Other
- No other prior therapy for lung cancer
- No other concurrent antineoplastic agents
- Concurrent participation in observational studies requiring bloodwork, radiographs, pulmonary function tests, or quality of life studies is allowed
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Nithya Ramnath, MD, Roswell Park Cancer Institute
Publicaties en nuttige links
Algemene publicaties
- Ramnath N, Sommers E, Anderson T, et al.: Neoadjuvant gemcitabine and vinorelbine in non-small-cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2818, 2003.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Gemcitabine
- Vinorelbine
Andere studie-ID-nummers
- CDR0000270753
- RPCI-RP-00-01
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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