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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00702975
Recruitment Status : Completed
First Posted : June 20, 2008
Last Update Posted : July 15, 2013
Information provided by (Responsible Party):
Radboud University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Locally Advanced Non-Small Cell Lung Cancer NSCLC Drug: Paclitaxel, Carboplatin and Bevacizumab,Erlotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2008
Actual Primary Completion Date : February 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Intervention Details:
  • Drug: Paclitaxel, Carboplatin and Bevacizumab,Erlotinib
    4 cycles (or less in case of progression) with carboplatin AUC 6 -paclitaxel 200mg/m2 -bevacizumab 15 mg/kg i.v. At (early) progress Bevacizumab 15 mg/kg i.v. q 21 days plus Erlotinib 150 mg/day orally
    Other Names:
    • Carboplatin (L01XA02)
    • Paxene (L01CD01)
    • Avastin(L01XC07)
    • Tarceva(L01XE03)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Efficacy of bevacizumab and erlotinib as determined by DCR; PFS; RR [ Time Frame: at 6, 12 and 27 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00702975

University Lung Centre Nijmegen Dekkerswald
Groesbeek, Gelderland, Netherlands, 6561 KE
Sponsors and Collaborators
Radboud University
Principal Investigator: J. Timmer-Bonte, MD, Phd UMCN st Radboud

Responsible Party: Radboud University Identifier: NCT00702975     History of Changes
Other Study ID Numbers: ULCN0107
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: April 2012

Keywords provided by Radboud University:
phase II
metastatic NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors