Overview

This trial is active, not recruiting.

Condition advanced non-squamous non-small cell lung cancer
Treatments carboplatin and pemetrexed with bevacizumab 7.5 mg/kg, carboplatin and pemetrexed with bevacizumab 15 mg/kg
Sponsor University of Chicago
Collaborator Genentech, Inc.
Start date March 2010
End date March 2018
Trial size 70 participants
Trial identifier NCT01063283, 10-014-B

Summary

The purpose of this study is to see if higher dose of bevacizumab can be taken safely by some patients and if changes in the dose of bevacizumab have any effect on blood pressure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses
carboplatin and pemetrexed with bevacizumab 7.5 mg/kg Carboplatin and Pemetrexed with Bevacizumab
Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses
(Active Comparator)
Carboplatin and Pemetrexed with Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses
carboplatin and pemetrexed with bevacizumab 15 mg/kg Carboplatin and Pemetrexed with Bevacizumab
Carboplatin and Pemetrexed with Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses

Primary Outcomes

Measure
Does a higher dose of bevacizumab have any effect on changes in blood pressure
time frame: 2 cycles

Secondary Outcomes

Measure
Response rate
time frame: 2 years
Change in tumor size
time frame: 2 years
Progression free survival
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 89 years old.

Inclusion Criteria: - Patients must have histologically or cytologically confirmed, newly diagnosed Stage IIIB, stage IV, or recurrent non-squamous NSCLC for which they have not received chemotherapy. - Patients must have completed radiation therapy 2 weeks prior to enrollment. Patients may have received adjuvant therapy, provided the regimen included no more than one of the study agents. - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension. - Age >18 years. •Life expectancy of greater than 4 months. - ECOG performance status of 0 or 1 - Patients must have normal organ and marrow function - Patients on anticoagulation are allowed. - Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Disease-Specific - Patients who have had received prior chemotherapy (in the setting of recurrent disease, other than their original adjuvant therapy) - Patients may not be receiving any other investigational agents. - Patients with histologic evidence of predominantly squamous lung cell cancer - General Medical Exclusions - Inability to comply with study and/or follow-up procedures - Malignancy other than superficial basal cell and superficial squamous of the skin or carcinoma in situ of the cervix within last five years Bevacizumab-Specific Exclusions - Inadequately controlled hypertension - Prior history of hypertensive crisis or hypertensive encephalopathy - New York Heart Association Grade II or greater congestive heart failure - History of myocardial infarction or unstable angina within 6 months prior to Day 1 - History of stroke or transient ischemic attack within 6 months prior to Day 1 - Known CNS disease, except for treated brain metastasis. - Significant vascular disease within 6 months prior to Day 1 - History of hemoptysis within 1 month prior to Day 1 - Evidence of bleeding diathesis or significant coagulopathy - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study - Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 - History of diverticulitis, abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 - Serious, non-healing wound, active ulcer, or untreated bone fracture - Proteinuria as demonstrated by a UPC ratio 1.0 at screening - Known hypersensitivity to any component of bevacizumab - Pregnancy (positive pregnancy test) or lactation. - Mixed tumors will be categorized by the predominant cell type unless small cell elements are present. - Uncontrolled intercurrent illness including, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements. - Any unstable condition that in the opinion of the investigator is likely to interfere with collection of accurate blood pressure measurement data . - HIV-positive patients on combination antiretroviral therapy.

Additional Information

Official title A Randomized, Open-Label, Dose Escalation Study of Bevacizumab With Ambulatory Blood Pressure Monitoring in Previously Untreated Patients With Advanced Non-squamous Non-Small Cell Lung Cancer
Principal investigator Michael Maitland, MD., Ph.d
Description Carboplatin and pemetrexed are FDA approved chemotherapy agents for patients with advanced non squamous non small cell lung cancer. Bevacizumab is also FDA approved in lung cancer , and the combination of all three drugs is promising. The doctors directing this research want to learn how to better personalize drug dosing of bevacizumab by identifying people who could safely take a higher dose of the drug.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Chicago.