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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00702975
First received: June 19, 2008
Last updated: July 12, 2013
Last verified: April 2012
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of bevacizumab and erlotinib as determined by DCR; PFS; RR [ Time Frame: at 6, 12 and 27 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: September 2008
Study Completion Date: June 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702975

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

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00702975     History of Changes
Other Study ID Numbers: ULCN0107
Study First Received: June 19, 2008
Last Updated: July 12, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
phase II
NSCLC
bevacizumab
erlotinib
metastatic NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Erlotinib
Bevacizumab
Carboplatin
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on July 26, 2014