Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer

NCT00675597 | Completed Results

• 1 other identifier: 07-178
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

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.

Conditions

Lung Cancer

Keywords

Bevacizumab (Avastin); Taxotere (Docetaxel); Vinorelbine Tartrate (Navelbine); 07-178

Outcome Measures

Primary Outcomes (1)

• To Measure the Number of Cycles

  Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.

  2 years

Study Arms (1)

1

EXPERIMENTAL

Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer

Drug: Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)

Interventions

Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine) DRUG

Patients will be treated as follows: vinorelbine (45 mg/m2) + docetaxel (45 mg/m2) intravenously on day 1, followed by pegylated filgrastim 6mg subcutaneously on day 2, delivered every 2 weeks for 8 doses total. Patients who have already received one cycle of cisplatin-based adjuvant chemotherapy need only complete 3 cycles of vinorelbine+docetaxel for a total of 4 cycles of adjuvant chemotherapy. Patients who require post-operative radiation therapy (PORT) will begin PORT after completion of vinorelbine + docetaxel.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Sanofi: collaborator

Study Sites (5)

Memorial Sloan-Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan-Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan-Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Sleepy Hollow, New York, 10591, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bevacizumab; Docetaxel; Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Dr. Mark G. Kris
• Organization: Memorial Sloan Kettering Cancer Center

Krism@mskcc.org

646-888-4205

Study Officials

• Christopher Azzoli, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 9, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 20, 2015
• Results First Posted: November 20, 2015

Record last verified: 2015-10

Locations

US (5)