Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

January 8, 2018 updated by: Alliance for Clinical Trials in Oncology

A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To determine the activity of induction chemotherapy comprising carboplatin and paclitaxel albumin-stabilized nanoparticle formulation followed by concurrent thoracic radiotherapy and erlotinib hydrochloride in patients with poor-risk, unresectable stage IIIA or IIIB non-small cell lung cancer.

Secondary

  • To determine the response rate and progression-free survival of these patients.

OUTLINE: Patients receive induction chemotherapy comprising paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study. Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy.

Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years

Study Type

Interventional

Enrollment (Actual)

78

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
    • California
      • Castro Valley, California, United States, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, United States, 94546
        • Valley Medical Oncology Consultants - Castro Valley
      • Fremont, California, United States, 94538
        • Valley Medical Oncology
      • Martinez, California, United States, 94553-3156
        • Contra Costa Regional Medical Center
      • Mountain View, California, United States, 94040
        • El Camino Hospital Cancer Center
      • Mountain View, California, United States, 94040
        • Camino Medical Group - Treatment Center
      • Oakland, California, United States, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, United States, 94602
        • Highland General Hospital
      • Oakland, California, United States, 94609
        • Larry G Strieff MD Medical Corporation
      • Oakland, California, United States, 94609
        • CCOP - Bay Area Tumor Institute
      • Oakland, California, United States, 94609
        • Bay Area Breast Surgeons, Incorporated
      • Oakland, California, United States, 94609
        • Tom K Lee, Incorporated
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation
      • San Pablo, California, United States, 94806
        • Doctors Medical Center - San Pablo Campus
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Poudre Valley Radiation Oncology
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Gainesville, Florida, United States, 32610-0232
        • University of Florida Shands Cancer Center
      • Jupiter, Florida, United States, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami Beach, Florida, United States, 33140
        • CCOP - Mount Sinai Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Hematology Oncology Associates of the Quad Cities
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's Hospital - South
      • Prairie Village, Kansas, United States, 66208
        • CCOP - Kansas City
    • Maine
      • Augusta, Maine, United States, 04330
        • Harold Alfond Center for Cancer Care
      • Bangor, Maine, United States, 04401
        • CancerCare of Maine at Eastern Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Veterans Affairs Medical Center - Baltimore
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
      • Bethesda, Maryland, United States, 20889-5600
        • National Naval Medical Center
      • Elkton, Maryland, United States, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University Cancer Research Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Dearborn, Michigan, United States, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Jackson, Michigan, United States, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, United States, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, United States, 48154
        • St. Mary Mercy Hospital
      • Pontiac, Michigan, United States, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, United States, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Warren, Michigan, United States, 48093
        • St. John Macomb Hospital
    • Mississippi
      • Pascagoula, Mississippi, United States, 39581
        • Regional Cancer Center at Singing River Hospital
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Institute at Saint Luke's Hospital
      • Kansas City, Missouri, United States, 64114
        • St. Joseph Medical Center
      • Kansas City, Missouri, United States, 64116
        • Parvin Radiation Oncology
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology Oncology Associates, Incorporated
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, United States, 64068
        • Liberty Hospital
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Saint Joseph, Missouri, United States, 64507
        • Saint Joseph Oncology, Incorporated
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, United States, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, United States, 68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68131-2197
        • Creighton University Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Nevada Cancer Research Foundation
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology - Hematology, PA - Hooksett
      • Laconia, New Hampshire, United States, 03246
        • Lakes Region General Hospital
      • Manchester, New Hampshire, United States, 03103
        • Elliot Regional Cancer Center at Elliot Hospital
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Buffalo, New York, United States, 14215
        • Veterans Affairs Medical Center - Buffalo
      • East Syracuse, New York, United States, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Glens Falls, New York, United States, 12801
        • Charles R. Wood Cancer Center at Glens Falls Hospital
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Kinston, North Carolina, United States, 28501
        • Kinston Medical Specialists
      • Lumberton, North Carolina, United States, 28359
        • Southeastern Regional Medical Center
      • Oxford, North Carolina, United States, 27565
        • Granville Medical Center
      • Raleigh, North Carolina, United States, 27607
        • Rex Cancer Center at Rex Hospital
      • Raleigh, North Carolina, United States, 27609
        • Duke Health Raleigh Hospital
      • Roxboro, North Carolina, United States, 27573
        • Person Memorial Hospital
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
      • Statesville, North Carolina, United States, 28677
        • Iredell Memorial Hospital
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Akron, Ohio, United States, 44309-2090
        • Summa Center for Cancer Care at Akron City Hospital
      • Barberton, Ohio, United States, 44203
        • Barberton Citizens Hospital
      • Canton, Ohio, United States, 44710-1799
        • Aultman Cancer Center at Aultman Hospital
    • Pennsylvania
      • Drexel Hill, Pennsylvania, United States, 19026
        • Delaware County Regional Cancer Center at Delaware County Memorial Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Tennessee
      • Kingsport, Tennessee, United States, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Regional Medical Center
      • Norton, Virginia, United States, 24273
        • Southwest Virginia Regional Cancer Center at Wellmonth Health
    • Washington
      • Yakima, Washington, United States, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center
      • Milwaukee, Wisconsin, United States, 53295
        • Veterans Affairs Medical Center - Milwaukee

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologies:

    • Squamous cell carcinoma
    • Adenocarcinoma (including bronchoalveolar cell)
    • Large cell anaplastic carcinoma (including giant and clear cell carcinomas)

  • Must meet the following criteria:

    • T1-3 with N2 and selected N3*
    • T4 with N0, N1, N2 and selected N3*
    • M0 (no M1 patients) NOTE: *Patients with contralateral mediastinal disease (i.e., N3) are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria. Patients with ipsilateral scalene or supraclavicular disease are also eligible. Patients with contralateral hilar or supraclavicular node involvement are not eligible.

  • Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

    • Nonmeasurable lesions include the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural or pericardial effusion
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Tumor lesions situated in a previously irradiated area
  • Patients must be considered unresectable or inoperable AND be deemed candidates for combined modality therapy by a medical oncologist and a radiation oncologist
  • Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10% weight loss within the past 3 months
  • Patients with tumors adjacent to a vertebral body are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria

  • Pleural effusions meeting the following criteria allowed:

    • Effusion is transudate, cytologically negative, and non-bloody
    • Effusion can be seen on the chest CT scan but not on the chest x-ray AND is too small to tap
    • Effusion appears only after a thoracotomy or other invasive thoracic procedure was attempted

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • Granulocytes ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Creatinine ≤ 1.5 x upper limit of normal (ULN)
  • AST < 2 x ULN
  • Bilirubin ≤ ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for NSCLC
  • At least 2 weeks since formal exploratory thoracotomy
  • No concurrent administration of sucralfate suspension and erlotinib hydrochloride
  • No concurrent intensity-modulated radiotherapy
  • No concurrent hormones or other chemotherapeutic agents except steroids given for adrenal failure, hormones administered for non-disease-related conditions (e.g., insulin for diabetes), and intermittent use of dexamethasone as an antiemetic
  • No concurrent palliative radiotherapy

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: paclitaxel + carboplatin + radiation + erlotinib

Patients receive paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study.

Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy.

Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years
Drug: carboplatin
Radiation: radiation therapy
Drug: erlotinib hydrochloride
Drug: paclitaxel albumin-stabilized nanoparticle formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival at 12 Months
Time Frame: At 12 months
Percentage of participants who were alive at 12 months.
At 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: Duration of study (up to 2 years)

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:

  • Complete Response (CR): disappearance of all target lesions;
  • Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
  • Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
  • Stable Disease (SD): small changes that do not meet above criteria.

Response rate is reported as the percentage of participants who achieved each response.
Duration of study (up to 2 years)
Progression-free Survival
Time Frame: Duration of study (up to 2 years)
Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.
Duration of study (up to 2 years)

Collaborators and Investigators

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Rogerio Lilenbaum, MD, Cleveland Clinic Florida

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

March 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

June 15, 2017

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimate)

November 4, 2007

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-30605
  • CDR0000573832 (Registry Identifier: NCI Physician Data Query)

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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