Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)

NCT00356122 | Completed Phase 2 Results

• 1 other identifier: DOCOX_L_00716
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.

Conditions

Non-Small Cell Lung Cancer

Keywords

Lung; non-small cell; chemotherapy; tumor; advanced; recurrent; metastatic; Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS was defined as the interval from the date of registration to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurred first. Progressive disease occurred when the participant had at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.

  Baseline to PFS (up to 24 months after the first treatment)

Secondary Outcomes (4)

• Objective Response Rate

  Baseline to CR or PR (up to 24 months after the first treatment)

• Time-to-treatment Failure (TTF)

  Baseline to treatment failure (up to 24 months after the first treatment)

• Overall Survival (OS)

  Baseline to OS (up to 24 months after the first treatment)

• Number of Participants With Treatment-related Toxicities

  From baseline up to 30 days after treatment discontinuation

Study Arms (1)

Docetaxel/Oxaliplatin/Bevacizumab

EXPERIMENTAL

Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of docetaxel, followed by oxaliplatin, and then bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.

Drug: Docetaxel; Drug: Oxaliplatin; Drug: Bevacizumab

Interventions

Docetaxel DRUG

70 mg/m\^2 administered intravenously (IV) on Day 1 for Cycles 1-6 (the treatment cycle is 3 weeks)

Docetaxel/Oxaliplatin/Bevacizumab

Oxaliplatin DRUG

100 mg/m\^2 administered IV on Day 1 for Cycles 1-6

Docetaxel/Oxaliplatin/Bevacizumab

Bevacizumab DRUG

15 mg/kg administered IV on Day 1 for Cycles 1-6, and every 3 weeks during maintenance therapy for a total treatment of one year, until disease progression or death due to any cause, whichever occurs first.

Docetaxel/Oxaliplatin/Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Participants who met all of the following criteria during screening were considered for enrollment into the study:
• Had the informed consent in writing for all prior to registration into the study
• Had histologic or cytologic confirmation of locally advanced or metastatic (stage IIIb/IV) NSCLC (non-squamous histology). Participants with mixed tumor types could have been enrolled, unless small cell elements were discovered
• Had measurable disease, defined as at least 1 lesion that could be accurately measured in at least 1 dimension (longest diameter) as ≥ 2.0 cm with conventional computerized tomography (CT) or magnetic resonance imaging (MRI) scans, or as ≥ 1.0 cm with spiral CT scan
• Had no prior systemic chemotherapy
• Was male or female ≥ 18 years old
• Had an estimated life expectance of ≥ 12 weeks
• Had an ECOG performance status (PS) of 0, 1, or 2
• Was a nonpregnant, nonlactating female Was a male or female of childbearing potential who was willing to use an effective form of contraception while on therapy and for 90 days thereafter.
• Had adequate renal function as determined by the following within 2 weeks prior to study registration.
• A calculated creatinine clearance greater than 45 mL/min using the Cockcroft-Gault formula
• A urine dipstick or urinalysis for protein \<2+ (Participants discovered to have ≥ 2+ proteinuria on dipstick or urinalysis at baseline had to undergo a 24 hour urine collection and had to have ≤ 1 gm of protein over 24 hours to be eligible).
• Had a hematologic evaluation within 2 weeks prior to study registration (and met the minimum values):
• Had absolute neutrophil count (ANC) ≥ 1,500 cells/microL
• Had platelet count ≥ 100,000 cells/microL

You may not qualify if:

• Participants with any of the following were not included in the study:
• Had received prior systemic chemotherapy or vascular endothelial growth factor (VEGF) or epidermal growth factor receptor (EGFR) inhibitor therapy at any time; or had received recent or current radiation therapy
• Had intrathoracic lung carcinoma of squamous cell histology. (Participants with extrathoracic-only squamous cell NSCLC were eligible. Participants with only peripheral lung lesions (of any NSCLC histology) were also eligible
• Had cardiovascular diseases and related treatment, including the following:
• New York Heart Association Class ≥ 2 congestive heart failure; participants with a history of serious cardiac disease not adequately controlled; or a history of myocardial infarction or unstable angina pectoris within 6 months prior to study registration
• History of stroke or transient ischemic attack within 6 months of study registration
• History of hypertensive crisis or hypertensive encephalopathy
• History of thrombotic or hemorrhagic disease
• Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
• Clinically meaningful peripheral vascular disease, or arrhythmia
• Inadequately controlled blood pressure (defined as systolic blood pressure \>150 mm Hg and/or diastolic blood pressure \>100 mm Hg)
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection) within 6 months prior to study registration
• Therapeutic anticoagulation (Participants receiving prophylactic anticoagulation for venous access devices were allowed providing they met certain criteria)
• Chronic daily treatment with aspirin (≥ 325 mg/day) or nonsteroidal anti-inflammatory agents known to inhibit platelet function; treatment with dipyridamole, ticlopidine, clopidogrel, or cilostazol was not allowed.
• Had a surgical procedure in anamnesis (medical history):

Sponsors & Collaborators

• Sanofi: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Recurrence; Neoplasm Metastasis

Interventions

Docetaxel; Oxaliplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi-Aventis

Contact-Us@sanofi.com

Study Officials

• Vicki Erickson, MSN

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 25, 2006
• Study Start: July 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 17, 2011
• Results First Posted: September 16, 2011

Record last verified: 2011-08

Locations

US (1)