Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Induction/Concurrent Chemotherapy and Dose-Escalated Three Dimensional Thoracic Radiation for Patients With Stage III Non Small Cell Lung Cancer: A Randomized Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033553
• Other study ID #: CALGB-30105
• Secondary ID: U10CA031946CALGB
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2002
• Last updated: July 15, 2016
• Start date: March 2002
• Est. completion date: June 2010

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan treatment may result in more effective radiation therapy. It is not yet known which chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectable stage III non-small cell lung cancer.

Description:

OBJECTIVES:

• Compare the overall response rate, failure-free survival, and survival of patients with inoperable stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel and carboplatin with concurrent 3-dimensional conformal radiotherapy (3-D XRT) vs gemcitabine and carboplatin with concurrent 3-D XRT.

• Compare the toxicity of these regimens in these patients.

• Compare the pattern of failure (locoregional vs distant failure) in patients treated with these regimens.

• Determine the feasibility of delivering 3-D XRT to patients in this multicenter study.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes once weekly and 3-dimensional conformal radiotherapy (3-D XRT) once daily 5 days a week. Treatment repeats weekly for 7 courses.

• Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive gemcitabine IV over 30 minutes twice weekly and 3-D XRT as in arm I. Treatment repeats weekly for 7 courses.

In both arms, treatment continues in the absence of disease progression.

Patients are followed every 2 months for 2 years, every 4 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 82 patients (41 per treatment arm) will be accrued for this study within 9 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 2010
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Squamous cell carcinoma

• Adenocarcinoma, including bronchoalveolar cell carcinoma

• Large cell anaplastic carcinoma, including giant and clear cell carcinoma

• Inoperable stage IIIA or IIIB disease

• No direct invasion of vertebral body

• Tumors adjacent to a vertebral body without bone invasion allowed if all gross disease can be encompassed in radiotherapy boost field

• Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in radiotherapy boost field

• No scalene, supraclavicular, or contralateral hilar node involvement

• Transudate, cytologically negative, non-bloody pleural effusion allowed if it can be encompassed in radiotherapy field

• No exudative, bloody, or cytologically malignant pleural effusion

• Evidence of pleural effusion by chest CT scan but not chest x-ray that is too small to tap allowed

• At least 1 unidimensionally measurable lesion

• At least 20 mm by conventional techniques OR

• At least 10 mm by spiral CT scan

• The following are not considered measurable disease:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Abdominal masses that are not confirmed and followed by imaging techniques

• Cystic lesions

• Tumor lesions in a previously irradiated field

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin less than 1.5 mg/dL

• AST less than 2 times upper limit of normal

Renal:

• Creatinine clearance 20-130 mL/min for females

• Creatinine clearance 20-150 mL/min for males

Pulmonary:

• FEV1 at least 1.2 L

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other currently active malignancy (defined as completed prior therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for NSCLC

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except steroids for adrenal failure or septic shock, hormones for non-disease-related conditions (e.g., insulin for diabetes), or glucocorticosteroids as antiemetics

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy for NSCLC

Surgery:

• At least 2 weeks since prior exploratory thoracotomy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• carboplatin
Arm A: AUC=6 IV over 30 min for 2 cycles then AUC=2 IV over 30 min q wk for 7 wks Arm B: AUC=5 IV over 30 min for 2 cycles
• gemcitabine hydrochloride
1000 mg/sq m IV over 30 min days 1 & 8 repeat q 21 days for 2 cycles; then 35 mg/sq m IV over 30 min 2X wk for 7 wks
• paclitaxel
225 mg/sq m IV over 3 hrs q 21 days for 2 cycles, then 45 mg/sq m IV over 1 hr q wk for 7 wks

Radiation:
• radiation therapy
3-D XRT 7400 cGy total after induction (during cycles 3-9)

Locations

Country	Name	City	State
United States	Northeast Alabama Regional Medical Center	Anniston	Alabama
United States	Veterans Affairs Medical Center - Asheville	Asheville	North Carolina
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Veterans Affairs Medical Center - Buffalo	Buffalo	New York
United States	Vermont Cancer Center at University of Vermont	Burlington	Vermont
United States	Cancer Institute of New Jersey at the Cooper University Hospital	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Martha Jefferson Hospital	Charlottesville	Virginia
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	NorthEast Oncology Associates - Concord	Concord	North Carolina
United States	Veterans Affairs Medical Center - Dallas	Dallas	Texas
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Veterans Affairs Medical Center - Durham	Durham	North Carolina
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	East Syracuse	New York
United States	Elmhurst Hospital Center	Elmhurst	New York
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	Fort Wayne Medical Oncology and Hematology, Incorporated	Fort Wayne	Indiana
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	Memorial Regional Cancer Center at Memorial Regional Hospital	Hollywood	Florida
United States	New Hampshire Oncology-Hematology, PA - Hooksett	Hooksett	New Hampshire
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Lenoir Memorial Cancer Center	Kinston	North Carolina
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Veterans Affairs Medical Center - Las Vegas	Las Vegas	Nevada
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center	Los Angeles	California
United States	Baptist Hospital East - Louisville	Louisville	Kentucky
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	North Shore University Hospital	Manhasset	New York
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Virginia Oncology Associates - Norfolk	Norfolk	Virginia
United States	Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Comprehensive Cancer Center at Moore Regional Hospital	Pinehurst	North Carolina
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Lifespan: The Miriam Hospital	Providence	Rhode Island
United States	MBCCOP - Massey Cancer Center	Richmond	Virginia
United States	West Suburban Center for Cancer Care	River Forest	Illinois
United States	Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke	Roanoke	Virginia
United States	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	Saint Joseph	Michigan
United States	Missouri Baptist Cancer Center	Saint Louis	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Naval Medical Center - San Diego	San Diego	California
United States	Veterans Affairs Medical Center - San Diego	San Diego	California
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Veterans Affairs Medical Center - San Francisco	San Francisco	California
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Veterans Affairs Medical Center - Syracuse	Syracuse	New York
United States	Lombardi Cancer Center at Georgetown University Medical Center	Washington	District of Columbia
United States	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Zimmer Cancer Center at New Hanover Regional Medical Center	Wilmington	North Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

Blackstock AW, Socinski MA, Bogart J, et al.: Induction (Ind) plus concurrent (Con) chemotherapy with high-dose (74 Gy) 3-dimensional (3-D) thoracic radiotherapy (TRT) in stage III non-small cell lung cancer (NSCLC): preliminary report of Cancer and Leuke

Blackstock AW, Socinski MA, Gu L, et al.: Initial pulmonary toxicity evaluation of chemoradiotherapy (CRT) utilizing 74 Gy 3-dimensional (3-D) thoracic radiation in stage III non-small cell lung cancer (NSCLC): a Cancer and Leukemia Group B (CALGB) random

Socinski MA, Blackstock AW, Bogart JA, Wang X, Munley M, Rosenman J, Gu L, Masters GA, Ungaro P, Sleeper A, Green M, Miller AA, Vokes EE. Randomized phase II trial of induction chemotherapy followed by concurrent chemotherapy and dose-escalated thoracic c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response	Response is assessed as failure free survival	18 months post treatment	No
Secondary	Overall Survival		6 years post treatment	No
Secondary	Toxicity	Toxicity will be assessed during treatment	13 weeks	Yes