Expired Study
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New York, New York 10021


Purpose:

This is a phase II, single institution trial for patients with clinical Stage IB-IIIA NSCLC (T1-3N0-2M0) who have resectable lung tumors. The primary goal of this study is to show that the addition of bevacizumab to a cisplatin-based chemotherapy in the neoadjuvant setting for non-squamous cell carcinomas improves the rate of pathologic downstaging, which correlates with survival. Downstaging is defined as any decrease in the final pathologic stage compared with the clinical stage before induction therapy.


Criteria:

Inclusion Criteria: - Pathologic confirmation of NSCLC at Memorial Sloan-Kettering Cancer Center (MSKCC) - Stages IB, IIA, IIB or IIIA (T1-3N0-2M 0) NSCLC - Patients must be candidates for resection with curative intent. - Measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions - Age >= 18 years - Karnofsky performance status >= 70% - Normal marrow function: leukocytes >= 3,000/µl; absolute neutrophil count ≥ 1,500µl; platelets >= 100,000 µl; hemoglobin >= 9gm/dl. - Adequate renal function, with creatinine <= 1.3 mg/dl or calculated creatinine clearance >= 60ml/min by Cockcroft-Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl) - Adequate hepatic function: total bilirubin within normal limits; AST <= 1.5 X upper limit of normal (UNL); ALT <= 1.5 X UNL; alkaline phosphatase <= 1.5 X UNL. - Women of childbearing age must have a negative urine or blood 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 must have ability to understand and the willingness to sign a written informed consent document. - Eligibility criteria for group B: Patients with SQUAMOUS CELL carcinoma or patients with a NON-SQUAMOUS CELL tumor with a large central tumor in proximity to significant blood vessels or any history of hemoptysis will be assigned to group B (preoperative chemotherapy alone without bevacizumab). Exclusion Criteria: - Prior chemotherapy or radiation therapy for NSCLC - Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF) - Patients with a history of severe hypersensitivity reaction to docetaxel (Taxotere) or other drugs formulated with polysorbate 80 - Patients with known hypersensitivity to other recombinant human antibodies - Patients must not be receiving any other investigational agents. - History of stroke or transient ischemic attack (TIA). - History of myocardial infarction or unstable angina within the past 12 months. - Patients who report a hearing deficit at baseline, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or higher) - Peripheral neuropathy > grade 1. - Uncontrolled hypertension - Esophageal varices, non-healing ulcer, wound, or bone fracture - Known HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs. - Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection. - Women who are pregnant or breast-feeding - Psychiatric illness or social situation that would limit compliance with study requirements - Exclusion criteria for group A: Patients with SQUAMOUS CELL carcinoma, large central tumor in proximity to significant blood vessels, or any history of hemoptysis (will be excluded from group A (preoperative chemotherapy plus bevacizumab); these patients will be assigned to group B (preoperative chemotherapy).


Study is Available At:


Original ID:

05-052


NCT ID:

NCT00130780


Secondary ID:


Study Acronym:


Brief Title:

Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) - BEACON Study: Bevacizumab and Chemotherapy for Operable NSCL


Official Title:

Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) (BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

71


Enrollment Type:

Actual


Overall Contact Information

Official Name:Naiyer Rizvi, M.D.
Principal Investigator
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:August 2005
Completion Date:October 2012
Completion Type:Actual
Primary Completion Date:October 2012
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 10, 2012
First Received Date:August 12, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:The primary goal of this study is to show that the addition of bevacizumab to cisplatin-based chemotherapy in the neoadjuvant setting for non-squamous cell carcinomas improves the rate of pathologic downstaging.
Time Frame:end of study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To determine the 3-year overall survival and median survival for stage IB-IIIA NSCLC patients treated with cisplatin-based chemotherapy ± bevacizumab (groups A and B combined)
Time Frame:end of study
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Pre-surgical Treatment with Bevacizumab plus Chemo
Description:On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab
Arm Name:A
Intervention Type:Drug
Name:Pre-Surgical Docetaxel and Cisplatin and Adjuvant
Description:Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total
Arm Name:B

Study Arms

Study Arm Type:Active Comparator
Arm Name:B
Description:Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab
Study Arm Type:Active Comparator
Arm Name:A
Description:Pre-surgical Treatment with Bevacizumab plus Chemotherapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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