Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery

NCT00057798 | Completed Phase 2 DMC

• 2 other identifiers: CDR0000270753RPCI-RP-00-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

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

Interventions

gemcitabine hydrochloride DRUG

vinorelbine ditartrate DRUG

cytogenetic analysis GENETIC

loss of heterozygosity analysis GENETIC

microarray analysis GENETIC

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Vinorelbine; Cytogenetic Analysis; Microarray Analysis; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Microchip Analytical Procedures; Combined Modality Therapy; Therapeutics

Study Officials

• Nithya Ramnath, MD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: March 1, 2000
• Primary Completion: May 1, 2003
• Study Completion: June 1, 2008
• Last Updated: March 8, 2011

Record last verified: 2011-03

Locations

US (1)