Lung Cancer
Conditions
Keywords
Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine), 07-178
Brief summary
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.
Interventions
DRUGBevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)
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.
Sponsors
Sanofi
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
* Patients must be at least 2 weeks status post complete (R0) surgical resection of pathologically-proven NSCLC (stage IA-IIIB). Pathology review will be performed independently at MSKCC. * Patients are eligible if they are unfit for cisplatin-based adjuvant chemotherapy based on specified clinical criteria (listed below). * Allergy to cisplatin * Baseline hearing loss (defined as any subjective baseline hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (CTCAE grade \> or equal to 2) * Baseline renal insufficiency (defined as a creatinine clearance of \< than or equal to 60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl). * Performance status 70% on the Karnofsky scale. * Congestive heart failure with New York Heart Association functional classification \> or equal to II, characterized by fatigue, dyspnea or other symptoms which limit activities of daily life. * Patient refuses to take cisplatin. * Age \> than or equal 18 * Performance Status Karnofsky \> than or equal to 70% * Peripheral neuropathy must be \< than grade 1 * Hematologic (minimal values) * Absolute neutrophil count \> than or equal to 1,500/mm3 * Hemoglobin \> than or equal to 8.0 g/dl * Platelet count \> than or equal to 100,000/mm3 Hepatic * Total Bilirubin \< than or equal to 1.5 x ULN AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility * Women of childbearing potential must have a negative pregnancy test. * Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. * Patients being considered for treatment with bevacizumab must have a urine protein: creatinine (UPC) ratio \< 1.0 at screening and an MRI of brain or CT brain with IV contrast showing no evidence of brain metastases within 3 months of study entry
Exclusion criteria
* \> 16 weeks post-op * Prior post-operative radiation * \> 1 cycle of prior adjuvant chemotherapy * Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. * Women who are pregnant, or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Measure the Number of Cycles | 2 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Docetaxel (Taxotere®) Plus Vinorelbine Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Docetaxel (Taxotere®) Plus Vinorelbine |
|---|---|
| Age, Continuous | 64.6 years |
| Sex: Female, Male Female | 11 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 | 23 / 23 |
| serious Total, serious adverse events | 13 / 23 |
Outcome results
Primary
To Measure the Number of Cycles
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.
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Docetaxel (Taxotere®) Plus Vinorelbine | To Measure the Number of Cycles | Completed 4 cycles | 20 participants |
| Docetaxel (Taxotere®) Plus Vinorelbine | To Measure the Number of Cycles | Unable to complete 4 cycles | 3 participants |