Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | May 2008 |
End Date: | February 2012 |
A Pilot Study of Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
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.
(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.
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.
We found this trial at
5
sites
701 N Broadway
Sleepy Hollow, New York 10591
Sleepy Hollow, New York 10591
(914) 366-3000

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Memorial Sloan Kettering Cancer Center Sleepy...
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials

1000 N Village Ave
Rockville Centre, New York 11570
Rockville Centre, New York 11570
(516) 256-3600

Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
Click here to add this to my saved trials
