Lung Cancer
Conditions
Keywords
Carboplatin, Cisplatin, Pemetrexed (Altima), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine), Stage IB-III, non squamous, non-small cell lung cancer, 11-106
Brief summary
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.
Interventions
DRUGpemetrexed
DRUGcisplatin
DRUGCarboplatin
DRUGGemcitabine Hydrochloride
DRUGVinorelbine Tartrate
DRUGDocetaxel
Sponsors
Eli Lilly and Company
United States Department of Defense
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologic confirmation of NSCLC at MSKCC * Stages IB, IIA, IIB, IIIA or IIIB NSCLC * Primary tumor must measure ≥ 2 cm on CT imaging (per PERCIST guidelines) * Primary tumor must be FDG-avid with an SUVmax \>4.5 (to be consistent with PERCIST guidelines) * Patients must be candidates for resection with curative intent * Age ≥ 18 years * Karnofsky performance status ≥ 70% * Normal bone marrow function * leukocytes ≥ 3,000/μl * absolute neutrophil count ≥ 1,500/μl * platelets ≥100,000/μl * hemoglobin ≥9gm/dl. * Adequate hepatic function * Total bilirubin ≤1.5 x ULN * AST ≤ 1.5 x UNL, ALT ≤ 1.5 x ULN * Alkaline phosphatase ≤ 1.5x ULN * Women of childbearing age must have a negative pregnancy test * Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter * Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Patients must not be receiving any other investigational agents * History of myocardial infarction or unstable angina within the past 12 months Patients with peripheral neuropathy \> grade 1 * Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection. * Patients with diabetes mellitus requiring insulin therapy (per PERCIST guidelines) * Patients with third space fluid which cannot be adequately controlled with drainage * Women who are pregnant or breast-feeding * Psychiatric illness or social situation that would limit compliance with study requirements * Patients with known HIV infection requiring antiretroviral medications and those with AIDS * Baseline subjective hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily living (CTCAE grade 2 or higher) * Baseline renal function \<60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl). * Congestive heart failure with New York Heart Association functional classification \> II, characterized by fatigue, dyspnea or other symptoms which limit activities of daily life. Selection of Pemetrexed versus Gemcitabine: Patients treated with pemetrexed must meet all of the following criteria: * Non-squamous histology * Patients must have the ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed * Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol * Patient refuses to take cisplatin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PERCIST Partial Metabolic Response | 2 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Response Rate | 2 years | The percentage of patients with a major pathologic response |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patient had brain mets | 1 |
| Overall Study | Responded to neoadjuvant platinum txt | 27 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 34 / 42 |
| serious Total, serious adverse events | 4 / 42 |
Outcome results
Primary
PERCIST Partial Metabolic Response
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).
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | PERCIST Partial Metabolic Response | 6 participants |
Secondary
Pathologic Response Rate
The percentage of patients with a major pathologic response
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Pathologic Response Rate | 17 percentage of patients |