Clinical trial NCT00675597: Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Bevacizumab (Avastin)
Taxotere (Docetaxel)
Vinorelbine Tartrate (Navelbine)
07-178
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2008-05-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To Measure the Number of Cycles
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan-Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center @ Suffolk
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan-Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christopher Azzoli, MD
role: PRINCIPAL_INVESTIGATOR
References: