Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): Christopher Azzoli, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
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.
Clinical Details
Official title: A Pilot Study of Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To measure the number of cycles of docetaxel + vinorelbine which can be delivered to patients with completely resected NSCLC (up to 4) in order to estimate whether tolerability is better than reported for standard cisplatin + vinorelbine.
Secondary outcome: To evaluate the safety of docetaxel + vinorelbine chemotherapy delivered to patients with completely resected NSCLC.To conduct an exploratory analysis of serial measurement of circulating DNA in blood as a way to track the effects of adjuvant chemotherapy.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Memorial Sloan-Kettering at Basking Ridge, Basking Ridge, New Jersey 07920, United States
Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack, New York 11725, United States
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States
Memorial Sloan-Kettering at Mercy Medical Center, Rockville Centre, New York, United States
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow, New York 10591, United States
Additional Information
Memorial Sloan-Kettering Cancer Center
Starting date: May 2008
Last updated: February 8, 2012
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