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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553462
• Other study ID #: CALGB-30605
• Secondary ID: CALGB-30605CDR00
• Status: Completed
• Phase: Phase 2
• First received: November 2, 2007
• Last updated: January 8, 2018
• Start date: March 2008
• Est. completion date: June 15, 2017

Study information

• Verified date: January 2018
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 15, 2017
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin

• erlotinib hydrochloride

• paclitaxel albumin-stabilized nanoparticle formulation

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio
United States	AnMed Cancer Center	Anderson	South Carolina
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	Harold Alfond Center for Cancer Care	Augusta	Maine
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland
United States	CancerCare of Maine at Eastern Maine Medical Center	Bangor	Maine
United States	Barberton Citizens Hospital	Barberton	Ohio
United States	National Naval Medical Center	Bethesda	Maryland
United States	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Veterans Affairs Medical Center - Buffalo	Buffalo	New York
United States	Aultman Cancer Center at Aultman Hospital	Canton	Ohio
United States	East Bay Radiation Oncology Center	Castro Valley	California
United States	Valley Medical Oncology Consultants - Castro Valley	Castro Valley	California
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care	Concord	New Hampshire
United States	Danville Regional Medical Center	Danville	Virginia
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Delaware County Regional Cancer Center at Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	Union Hospital of Cecil County	Elkton	Maryland
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Poudre Valley Radiation Oncology	Fort Collins	Colorado
United States	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	Valley Medical Oncology	Fremont	California
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	New Hampshire Oncology - Hematology, PA - Hooksett	Hooksett	New Hampshire
United States	Foote Memorial Hospital	Jackson	Michigan
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	Heartland Hematology Oncology Associates, Incorporated	Kansas City	Missouri
United States	North Kansas City Hospital	Kansas City	Missouri
United States	Parvin Radiation Oncology	Kansas City	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri
United States	St. Joseph Medical Center	Kansas City	Missouri
United States	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Kinston Medical Specialists	Kinston	North Carolina
United States	Lakes Region General Hospital	Laconia	New Hampshire
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri
United States	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware
United States	Liberty Hospital	Liberty	Missouri
United States	St. Mary Mercy Hospital	Livonia	Michigan
United States	Southeastern Regional Medical Center	Lumberton	North Carolina
United States	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire
United States	Contra Costa Regional Medical Center	Martinez	California
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee	Milwaukee	Wisconsin
United States	Camino Medical Group - Treatment Center	Mountain View	California
United States	El Camino Hospital Cancer Center	Mountain View	California
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Southwest Virginia Regional Cancer Center at Wellmonth Health	Norton	Virginia
United States	Alta Bates Summit Medical Center - Summit Campus	Oakland	California
United States	Bay Area Breast Surgeons, Incorporated	Oakland	California
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Highland General Hospital	Oakland	California
United States	Larry G Strieff MD Medical Corporation	Oakland	California
United States	Tom K Lee, Incorporated	Oakland	California
United States	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	Menorah Medical Center	Overland Park	Kansas
United States	Saint Luke's Hospital - South	Overland Park	Kansas
United States	Granville Medical Center	Oxford	North Carolina
United States	Palo Alto Medical Foundation	Palo Alto	California
United States	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	CCOP - Kansas City	Prairie Village	Kansas
United States	Duke Health Raleigh Hospital	Raleigh	North Carolina
United States	Rex Cancer Center at Rex Hospital	Raleigh	North Carolina
United States	Person Memorial Hospital	Roxboro	North Carolina
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Saint Joseph Oncology, Incorporated	Saint Joseph	Missouri
United States	Doctors Medical Center - San Pablo Campus	San Pablo	California
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Iredell Memorial Hospital	Statesville	North Carolina
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	St. John Macomb Hospital	Warren	Michigan
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina
United States	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival at 12 Months	Percentage of participants who were alive at 12 months.	At 12 months
Secondary	Response Rate	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)
Secondary	Progression-free Survival	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)