Carboplatin, Abraxane, and Bevacizumab in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer

February 23, 2017 updated by: Rebecca Suk Heist, MD, Massachusetts General Hospital

A Phase II Trial of Carboplatin, Abraxane, and Bevacizumab in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer

The purpose of this research study is to learn more about whether the combination of drugs carboplatin, Abraxane and Avastin helps treat non-small cell lung cancer (NSCLC). One of the standard treatments for advanced NSCLC is the combination of the drugs carboplatin, paclitaxel and Avastin. Paclitaxel can be associated with severe side effects that may make the treatment difficult to tolerate. Some of these side effects are caused by the solution used to dissolve paclitaxel before it can be administered. Abraxane is a different form of paclitaxel that does not need to be dissolved by this solution. Abraxane is approved for the treatment of breast cancer but is not approved to treat NSCLC. We will also be trying to learn more about how the drug Avastin may work to treat cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Participants will receive a single dose of Avastin 2 weeks before they are scheduled to start the combination of carboplatin, Abraxane and Avastin. Before the dose of Avastin is given, a perfusion CT scan and blood work will be performed. The perfusion CT scan and blood draw will be repeated 12 days after teh Avastin dose (2 days before beginning study treatment).
  • The combination of carboplatin, Abraxane and Avastin will be given in 3 week cycles and all drugs will be given as infusions. On day 1, Avastin, Abraxane and carboplatin wil be given. On Day 8 and 15, Abraxane will be given.

Participants can receive up to 6 cycles of carboplatin, Abraxane and Avastin if their disease does not get worse and they do not experience intolerable side effects.

  • The following assessment procedures will be performed on day 1 of each cycle: physical exam; routine urine test (every other cycle); Performance status assessment. Routine blood tests will be performed on days 1, 8 and 15.
  • Additional procedures performed after cycles 2 and 4 and at 6 months after beginning study treatment are as follows: CT scan, PET scan, perfusion CT and blood work.
  • After 6 cycles of carboplatin, Abraxane and Avastin, participants will receive Avastin alone for three weeks. Participants can continue to receive Avastin as long as they do not experience unacceptable side effects.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of non-small cell lung carcinoma of non-squamous histology
  • AJCC stage IIIB or Stage IV
  • Measurable disease by RECIST criteria, and must have at least one target lesion 1cm or greater in diameter for optimal perfusion CT scanning
  • No prior chemotherapy treatment or VEGF inhibitor treatment, although prior treatment with EGFR inhibitors will be allowed
  • 18 years of age or older
  • Adequate bone marrow, renal and liver function as outlined in the protocol

Exclusion Criteria:

  • Life expectancy of less than 12 weeks
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
  • Inadequately controlled hypertension
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • NYHA Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • History of stroke, transient ischemic attack within 6 months prior to study enrollment
  • Symptomatic CNS metastases or newly diagnosed CNS metastases that have not yet been definitively treated with radiation and/or surgery. Note that patients with a history of CNS metastases or cord compression are allowed if they have been definitively treated and are clinically stable. Maintenance steroids are allowed. Two weeks need to elapse from the completion of radiation, or 4 weeks from surgery, before starting avastin. Patients do have to remain clinically asymptomatic.
  • Significant vascular disease
  • Symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major medical surgical procedure during the course of the study
  • Minor surgical procedure, excluding FNA, core biopsy or placement of a vascular access device, within 7 days prior to study enrollment
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  • Serious, non-healing wound, ulcer, or bone fracture
  • Proteinuria at screening
  • Pregnant or lactating
  • Lung carcinoma of squamous cell histology
  • History of hemoptysis within 3 months prior to study enrollment
  • Current, on-going treatment with full-dose warfarin or its equivalent at the onset of treatment
  • Current or recent (within 10 days of enrollment) use of aspirin or chronic use of other NSAIDs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chemotherapy
Carboplatin, nab-paclitaxel, and bevacizumab
Drug: Bevacizumab
IV infusion
Drug: carboplatin
Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles
Drug: Nab-paclitaxel
Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month Progression Free Survival Rate
Time Frame: 6 Months
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate to Carboplatin, Abraxane and Avastin
Time Frame: 3 years
Objective response rate to carboplatin, Abraxane and Avastin according to Response Evaluation Criteria in Solid Tumors [Version 1.0]
3 years
6 Month Survival Rate
Time Frame: 6 months
The percentage of participants surviving at least six months after baseline
6 months
Overall Survival
Time Frame: 3 years
The median overall survival in months
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute
Genentech, Inc.
Celgene Corporation

Investigators

  • Principal Investigator: Rebecca Heist, MD MPH, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

March 21, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (ESTIMATE)

March 25, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-339

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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