Status:
COMPLETED
Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Sanofi
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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, th...
Eligibility Criteria
Inclusion
- 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
- \> 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00675597
Start Date
May 1 2008
End Date
February 1 2012
Last Update
November 20 2015
Active Locations (5)
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1
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York, United States