Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy

July 12, 2013 updated by: Radboud University Medical Center

A Phase II Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy

A phase II study of combination therapy of carboplatin -gemcitabine plus bevacizumab beyond progression in patients with locally advanced and/or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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

  • Netherlands
    • Gelderland
      • Groesbeek, Gelderland, Netherlands, 6561 KE
        • University Lung Centre Nijmegen Dekkerswald

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:

  • Advanced stage NSCLC (IIIB with malignant pleural effusion or stage IV excluding squamous cell histology, with measurable or evaluable disease.
  • No prior systemic therapy for advanced NSCLC, prior therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry.
  • Palliative radiotherapy to painful bony metastases will be permitted prior to study entry if completed prior to initiation of study treatment, and there are no residual sequelae of therapy such as bone marrow suppression.
  • Life expectancy of at least 3 months.
  • ECOG Performance status 0-1 (see appendix 2)
  • Age 18 or higher.
  • Female patients with reproductive potential must have a negative serum pregnancy test within 72 hours prior to start of study medication. All female patients of childbearing potential, and all male patients, must agree to use a medically acceptable method of contraception or agree to be abstinent throughout the treatment period and for 3 months after discontinuation of treatment
  • Patients must have normal organ and marrow function

Exclusion Criteria:

  • Prior systemic treatment for advanced NSCLC. One prior regimen (up to 4 cycles) of neoadjuvant or adjuvant therapy for early stage disease will be allowed if completed at least 6 months prior to study entry.
  • Known brain metastases (in case of clinical signs or symptoms of brain metastases radiological evaluation is mandatory).
  • Prior treatment with bevacizumab or erlotinib.
  • History of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab or erlotinib.
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study.
  • Concomitant chemotherapy, radiotherapy or investigational agents.
  • Evidence of bleeding diathesis or coagulopathy.
  • Use of full dose anti-coagulant agents.
  • Pregnant (positive pregnancy test) or lactating women.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start, anticipation of need for major surgical procedure during the course of the study.
  • Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to start.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to start.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, or with significant cavitation as assessed by treating investigator in consultation with an attending radiologist.
  • History of hemoptysis (bright red blood of 2.5 ml or more).
  • Significant co-morbidities including:
  • No uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg)
  • Unstable angina
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction within 6 months
  • History of stroke within 6 months
  • Clinically significant peripheral vascular disease
  • Patients diagnosed with a trachea-oesophageal fistula
  • Another active malignancy except for non-melanoma skin cancers in the last 5 years.
  • Inability to comply with study and/or follow-up procedures.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of erlotinib plus bevacizumab subsequent to the combination of carboplatin, paclitaxel and bevacizumab as determined by the maximum achieved disease control rate
Time Frame: at 18 weeks
at 18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of bevacizumab and erlotinib as determined by DCR; PFS; RR
Time Frame: at 6, 12 and 27 weeks
at 6, 12 and 27 weeks

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: J. Timmer-Bonte, MD, Phd, UMCN st Radboud

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

September 1, 2008

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (ESTIMATE)

June 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 15, 2013

Last Update Submitted That Met QC Criteria

July 12, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULCN0107

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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