AzTrials
AzTrials

Lung CancerPhase 2NCT00057798

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

A Phase 2 study testing gemcitabine hydrochloride, vinorelbine ditartrate and cytogenetic analysis in people with Lung Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
gemcitabine hydrochloride, vinorelbine ditartrate and cytogenetic analysis
Type of treatment
Surgery or procedure
How many people
21 participants
Where
1 siteUnited States
Study dates
Mar 2000to Jun 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Conditions
Lung Cancer
Being tested
gemcitabine hydrochloride, vinorelbine ditartrate, cytogenetic analysis, loss of heterozygosity analysis, microarray analysis
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
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2003 (estimated)
  2. Study startMar 2000
  3. Primary completionMay 2003
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00057798
Sponsor's protocol ID
CDR0000270753
Other IDs
RPCI-RP-00-01
Status last verified
Mar 2011
First submitted
7 Apr 2003
Last updated
8 Mar 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride, vinorelbine ditartrate and cytogenetic analysis in people with Lung Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00057798, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in