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Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00280150
First Posted: January 20, 2006
Last Update Posted: June 19, 2017
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.
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
  Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with bevacizumab, radiation therapy, and erlotinib may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of bevacizumab and erlotinib when given together with combination chemotherapy and radiation therapy and to see how well they work in treating patients with stage III non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer Biological: bevacizumab Drug: carboplatin Drug: erlotinib hydrochloride Drug: paclitaxel Radiation: 3-dimensional conformal radiation therapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Induction Carboplatin/Paclitaxel With Bevacizumab Followed by Concurrent Thoracic Conformal Radiation Therapy With Carboplatin/Paclitaxel, Bevacizumab and Erlotinib in Stage IIIA/B Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008]) [ Time Frame: 6 weeks after completion of therapy ]
    Dose-limiting toxicities (DLTs) were used to establish which cohort would be used for the phase II portion of the trial. DLTs were defined as any grade 3 or 4 nonhematologic toxicity with the exception of esophagitis, which had to be grade 4; grade 4 neutropenia lasting greater than or equal to 7 days and thrombocytopenia to less than 20,000/microliter.

  • Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy [ Time Frame: 6 weeks after completion of therapy ]
    A list of Hematologic and nonhematologic toxicities associated with induction and concurrent therapy. This includes the percentage of patients who experienced grades 2-4 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0).


Secondary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: 5 years ]
    The length of time during and after the treatment of a stage IIIA/B NSCLC that a patient lives with the disease but it does not get worse. 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.

  • Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II) [ Time Frame: 5 years ]

    Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement. The same method of assessment and the same techniques should be used to characterize each identified and reported lesion at baseline and during follow-up.

    Complete Response (CR)- Disappearance of all target lesions


  • Overall Response Rate and Survival Profile [ Time Frame: 5 years ]
    The overall response rate (ORR) to the two cycles of induction therapy plus bevacizumab in stage IIIA/B NSCLC. ORR is the portion of patients with a tumor size reduction for a minimum time period. Response duration is measured from the time of initial response until documented tumor progression.

  • Feasibility and Tolerability of Administering Consolidation Therapy [ Time Frame: 6 cycles ]
    The proportion of patients who were able to complete consolidation therapy after induction therapy and chemoradiotherapy


Enrollment: 46
Study Start Date: January 2006
Study Completion Date: January 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Bevacizumab 10 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
Biological: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Radiation: 3-dimensional conformal radiation therapy
Given 5 days a week for 7 weeks
Experimental: Cohort 2
Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
Biological: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: erlotinib hydrochloride
Given orally
Drug: paclitaxel
Given IV
Radiation: 3-dimensional conformal radiation therapy
Given 5 days a week for 7 weeks
Experimental: Cohort 3
Bevacizumab + Erlotinib 150 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
Biological: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: erlotinib hydrochloride
Given orally
Drug: paclitaxel
Given IV
Radiation: 3-dimensional conformal radiation therapy
Given 5 days a week for 7 weeks
Experimental: Phase II
Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
Biological: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: erlotinib hydrochloride
Given orally
Drug: paclitaxel
Given IV
Radiation: 3-dimensional conformal radiation therapy
Given 5 days a week for 7 weeks

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of non-small cell lung cancer

    • Stage IIIA or IIIB disease
    • No malignant pleural or pericardial effusions
    • No palpable supraclavicular adenopathy
  • Squamous cell histology allowed provided there is no hemoptysis and no central invasive lesions that abut or invade major blood vessels in the chest (with or without cavitation)
  • Considered suitable and appropriate for combined modality therapy and thoracic conformal radiotherapy, as determined by the treating medical and radiation oncologist

PATIENT CHARACTERISTICS:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Hemoglobin ≥ 9.0 mg/dL
  • Platelet count ≥ 100,000/mm³
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Forced expiratory volume 1 (FEV_1) ≥ 1 L
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 times ULN
  • Bilirubin normal
  • Partial thromboplastin time (PTT) and international normalized ratio (INR) normal
  • Urine protein:creatinine ratio < 1.0
  • Blood pressure ≤ 150/100 mm Hg on 3 separate occasions
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant recent hemoptysis (> ½ teaspoon of bright red blood)
  • No unstable angina
  • No New York Heart Association (NYHA) congestive heart failure ≥ class II
  • No myocardial infarction or stroke within the past 6 months
  • No clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No serious, non-healing wound, ulcer, or bone fracture
  • No thrombosis requiring therapeutic anticoagulation
  • No significant traumatic injury within the last 28 days

PRIOR CONCURRENT THERAPY:

  • Recovered from prior surgery
  • At least 4 weeks since prior and no concurrent participation in another experimental drug study
  • At least 4 weeks since prior and no concurrent major surgical procedure or open biopsy
  • At least 2 weeks since prior mediastinoscopy or mediastinotomy
  • At least 1 week since prior fine needle aspirations or core biopsies
  • No other concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
  • No other concurrent investigational agents
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00280150


Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Genentech, Inc.
Eli Lilly and Company
Investigators
Principal Investigator: Thomas Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center
Principal Investigator: Thomas A. Stinchcombe, MD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00280150     History of Changes
Other Study ID Numbers: LCCC 0511
UNC IRB 05-2091
First Submitted: January 19, 2006
First Posted: January 20, 2006
Results First Submitted: March 24, 2017
Results First Posted: June 19, 2017
Last Update Posted: June 19, 2017
Last Verified: May 2017

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Erlotinib Hydrochloride
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors