CompletedNot applicableNCT00675597

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.

Checked against the public recordLast updated Nov 20, 2015 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations5
SponsorMemorial Sloan Kettering Cancer Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Memorial Sloan Kettering Cancer Center
Interventions being studied
Drug: Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey
  • Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York
  • Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 20, 2015. Always confirm current availability with the study team.

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