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Molecular And Genetic Changes In Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Vinorelbine And Gemcitabine - Phase II Study


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Molecular And Genetic Changes In Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Vinorelbine And Gemcitabine - Phase II Study


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Principal Investigator

Nithya Ramnath, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000270753

NCT ID:

NCT00057798

Start Date:

March 2000

Completion Date:

June 2008

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263