N/A
Completed N=26
Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00675597 ↗Enrolled (actual)
26
Serious AEs
56.5%
Results posted
Nov 2015
Primary outcomePrimary: To Measure the Number of Cycles — 20; 3 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Measure the Number of Cycles |
20; 3 | — |
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 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 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 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.
Data sourced from ClinicalTrials.gov (NCT00675597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.