Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Bevacizumab

Vinorelbine

Cisplatin

Lenograstim

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tubulin Modulators

Antimitotic Agents

Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer

Patients will be treated as follows: vinorelbine (45 mg/m2) + docetaxel (45 mg/m2) intravenously on day 1, followed by pegylated filgrastim 6mg subcutaneously on day 2, delivered every 2 weeks for 8 doses total. Patients who have already received one cycle of cisplatin-based adjuvant chemotherapy need only complete 3 cycles of vinorelbine+docetaxel for a total of 4 cycles of adjuvant chemotherapy. Patients who require post-operative radiation therapy (PORT) will begin PORT after completion of vinorelbine + docetaxel.

Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)

Christopher Azzoli, MD

The purpose of this study is to determine whether a combination of the drugs docetaxel (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients.

Another purpose of this study is to determine whether a third drug, bevacizumab (Avastin®), may be delivered safely with docetaxel plus vinorelbine in patients who are eligible to receive bevacizumab.

Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer

A Pilot Study of Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer

Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.

Sanofi

Memorial Sloan Kettering Cancer Center

Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer

Docetaxel (Taxotere®) Plus Vinorelbine

Age, Continuous

Sex: Female, Male

Dr. Mark G. Kris

Completed 4 cycles

Unable to complete 4 cycles

To Measure the Number of Cycles

Overall Study

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Micronutrients

Hematinics

Vitamins

Gemcitabine

Carboplatin

Pemetrexed

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

This is a phase 2 clinical trial for patients with clinical Stage IB-III resectable and operable non-small cell lung cancer, evaluating whether the switch to an alternative, non-platinum neoadjuvant chemotherapy is safe and effective in patients who do not respond to neoadjuvant platinum-based chemotherapy. Those who fail to respond to platinum-based chemotherapy will be switched to the alternative neoadjuvant chemotherapy vinorelbine 45 mg/m2 and docetaxel 45 mg/m2 on day 1 followed by pegylated filgrastim on day 2, repeated every 2 weeks for 4 doses, followed by repeat FDG PET and CT scan.

pemetrexed

cisplatin

Gemcitabine Hydrochloride

Vinorelbine Tartrate

Jamie E. Chaft, MD

The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach has on the cancer.

It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery.

In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin.

Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)

Phase II Trial of Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)

The primary endpoint was partial metabolic response after 2 cycles of "switch" therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline).

The percentage of patients with a major pathologic response

Eli Lilly and Company

United States Department of Defense

There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.

Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer	NCT00675597	Lung Cancer	Bevacizumab (Av...	18 Years -	Memorial Sloan Kettering Cancer Center
Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)	NCT01443078	Lung Cancer	pemetrexed cisplatin Carboplatin Gemcitabine Hyd... Vinorelbine Tar... Docetaxel	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for vinorelbine tartrate (navelbine)