search
Back to results

Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cisplatin
irinotecan hydrochloride
radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring limited stage small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer by one of two methods: Fine needle aspiration biopsy Two positive sputa Must have limited disease as defined by all of the following: Stage I-IIIB Confined to 1 hemithorax No T4 tumor based on malignant pleural or pericardial effusion Patients with pleural effusion too small to tap under CT guidance and not evident on chest x-ray are allowed No N3 disease based on contralateral hilar or contralateral supraclavicular involvement Measurable or evaluable disease Tumor must be able to be encompassed by specified radiotherapy fields without unacceptable risk of serious pulmonary compromise No complete tumor resection No pericardial effusion (regardless of cytology) PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 120,000/mm^3 Hepatic Bilirubin no greater than 1.5 mg/dL No known Gilbert's disease Renal Creatinine no greater than 1.5 mg/dL Cardiovascular No myocardial infarction within the past 6 months No symptomatic heart disease Pulmonary Forced expiratory volume (FEV)_1 at least 1.0 L/sec No uncontrolled bronchospasms No uncompensated chronic obstructive pulmonary disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No pre-existing peripheral neuropathy grade 2 or greater No other malignancy within the past 2 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the bladder or cervix No other concurrent serious medical illness PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy No concurrent intensity-modulated radiotherapy Surgery See Disease Characteristics Other At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out period At least 14 days since prior Hypericum perforatum (St. John's wort) No concurrent EIACDs No concurrent amifostine during chemoradiotherapy Concurrent gabapentin or other non-EIACDs allowed

Sites / Locations

  • Comprehensive Cancer Center at University of Alabama at Birmingham
  • Providence Saint Joseph Medical Center - Burbank
  • Saint Rose Hospital
  • Valley Memorial Hospital
  • Highland General Hospital at St. George's University School of Medicine
  • CCOP - Bay Area Tumor Institute
  • Summit Medical Center
  • J.C. Robinson, M.D. Regional Cancer Center
  • CCOP - Christiana Care Health Services
  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  • University of Florida Shands Cancer Center
  • Memorial Cancer Institute at Memorial Regional Hospital
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  • CCOP - Mount Sinai Medical Center
  • Baptist-South Miami Regional Cancer Program
  • University of Chicago Cancer Research Center
  • Wendt Regional Cancer Center at Finley Hospital
  • Massachusetts General Hospital Cancer Center
  • William Beaumont Hospital - Royal Oak Campus
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • Monmouth Medical Center
  • Fox Chase Virtua Health Cancer Program - Marlton
  • AtlantiCare Regional Medical Center
  • Tucker Center for Cancer Care at Orange Regional Medical Center
  • SUNY Upstate Medical University Hospital
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Duke Comprehensive Cancer Center
  • Wayne Memorial Hospital, Incorporated
  • Wayne Radiation Oncology
  • Wilson Medical Center
  • McDowell Cancer Center at Akron General Medical Center
  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Albert Einstein Cancer Center
  • Mercy Cancer Institute at Mercy Hospital
  • Bon Secours St. Francis Health System
  • Greenville Hospital System Cancer Center
  • CCOP - Greenville
  • Sarah Cannon Cancer Center at Parkridge Medical Center
  • Vanderbilt-Ingram Cancer Center
  • M.D. Anderson Cancer Center at University of Texas
  • Cottonwood Hospital Medical Center
  • McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center - Provo
  • Utah Cancer Specialists at UCS Cancer Center
  • LDS Hospital
  • Dixie Regional Medical Center
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequence A: Level 1

Sequence B: Level 1

Sequence A: Level 2

Sequence B: Level 2

Sequence A: Level 3

Sequence B: Level 3

Arm Description

Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID

Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily

Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID

Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily

Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID

Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily

Outcomes

Primary Outcome Measures

Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity

Secondary Outcome Measures

Rate of non-dose limiting toxicity

Full Information

First Posted
May 6, 2003
Last Updated
November 14, 2015
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00059761
Brief Title
Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Official Title
Phase I Study of Irinotecan and Cisplatin in Combination With Twice Daily Thoracic Radiotherapy (45 Gy) or Once Daily Thoracic Radiotherapy (70 Gy) for Patients With Limited Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effect on the body when combining irinotecan and cisplatin with radiation therapy in treating patients who have limited-stage small cell lung cancer that could not be completely removed during surgery.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose of irinotecan administered with cisplatin and thoracic radiotherapy (given at two different schedules) in patients with limited stage small cell lung cancer. Determine the qualitative and quantitative toxicity and non-dose-limiting toxicity of these regimens in these patients. Determine the reversibility of all toxic effects associated with these regimens in these patients. OUTLINE: This is a non-randomized, dose-escalation study of irinotecan. Patients are assigned to 1 of 2 radiotherapy (RT) treatment groups. Radiotherapy: Group I: Patients undergo thoracic RT twice daily, 5 days a week, for 3 weeks. Group II: Patients undergo thoracic RT once daily, 5 days a week, for 7 weeks. Concurrent chemotherapy: Patients receive irinotecan IV over 60-90 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 1 course for group I and 2 courses for group II. Post RT chemotherapy: Patients receive irinotecan and cisplatin as above for 3 courses for group I and 2 courses, beginning after RT is complete, for group II. Sequential cohorts of 6 patients per group receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year and then 6 months for 4 years. PROJECTED ACCRUAL: A total of 12-36 patients (6-18 per group) will be accrued for this study within 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
limited stage small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence A: Level 1
Arm Type
Experimental
Arm Description
Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
Arm Title
Sequence B: Level 1
Arm Type
Experimental
Arm Description
Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
Arm Title
Sequence A: Level 2
Arm Type
Experimental
Arm Description
Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
Arm Title
Sequence B: Level 2
Arm Type
Experimental
Arm Description
Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
Arm Title
Sequence A: Level 3
Arm Type
Experimental
Arm Description
Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
Arm Title
Sequence B: Level 3
Arm Type
Experimental
Arm Description
Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity
Time Frame
From the start of treatment until 90 days
Secondary Outcome Measure Information:
Title
Rate of non-dose limiting toxicity
Time Frame
From start of treatment to the end of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer by one of two methods: Fine needle aspiration biopsy Two positive sputa Must have limited disease as defined by all of the following: Stage I-IIIB Confined to 1 hemithorax No T4 tumor based on malignant pleural or pericardial effusion Patients with pleural effusion too small to tap under CT guidance and not evident on chest x-ray are allowed No N3 disease based on contralateral hilar or contralateral supraclavicular involvement Measurable or evaluable disease Tumor must be able to be encompassed by specified radiotherapy fields without unacceptable risk of serious pulmonary compromise No complete tumor resection No pericardial effusion (regardless of cytology) PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 120,000/mm^3 Hepatic Bilirubin no greater than 1.5 mg/dL No known Gilbert's disease Renal Creatinine no greater than 1.5 mg/dL Cardiovascular No myocardial infarction within the past 6 months No symptomatic heart disease Pulmonary Forced expiratory volume (FEV)_1 at least 1.0 L/sec No uncontrolled bronchospasms No uncompensated chronic obstructive pulmonary disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No pre-existing peripheral neuropathy grade 2 or greater No other malignancy within the past 2 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the bladder or cervix No other concurrent serious medical illness PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy No concurrent intensity-modulated radiotherapy Surgery See Disease Characteristics Other At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out period At least 14 days since prior Hypericum perforatum (St. John's wort) No concurrent EIACDs No concurrent amifostine during chemoradiotherapy Concurrent gabapentin or other non-EIACDs allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey J. Langer, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Werner-Wasik, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Providence Saint Joseph Medical Center - Burbank
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Saint Rose Hospital
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
Valley Memorial Hospital
City
Livermore
State/Province
California
ZIP/Postal Code
94550
Country
United States
Facility Name
Highland General Hospital at St. George's University School of Medicine
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Summit Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
J.C. Robinson, M.D. Regional Cancer Center
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Baptist-South Miami Regional Cancer Program
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Wendt Regional Cancer Center at Finley Hospital
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program - Marlton
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
AtlantiCare Regional Medical Center
City
Pomona
State/Province
New Jersey
ZIP/Postal Code
08240
Country
United States
Facility Name
Tucker Center for Cancer Care at Orange Regional Medical Center
City
Middletown
State/Province
New York
ZIP/Postal Code
10940
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wayne Radiation Oncology
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wilson Medical Center
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893
Country
United States
Facility Name
McDowell Cancer Center at Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Mercy Cancer Institute at Mercy Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Bon Secours St. Francis Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Greenville Hospital System Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Sarah Cannon Cancer Center at Parkridge Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cottonwood Hospital Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Regional Medical Center - Provo
City
Provo
State/Province
Utah
ZIP/Postal Code
84603
Country
United States
Facility Name
Utah Cancer Specialists at UCS Cancer Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Dixie Regional Medical Center
City
St. George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Langer CJ, Swann S, Werner-Wasik M, et al.: Phase I study of irinotecan (Ir) and cisplatin (DDP) in combination with thoracic radiotherapy (RT), either twice daily (45 Gy) or once daily (70 Gy), in patients with limited (Ltd) small cell lung carcinoma (SCLC): early analysis of RTOG 0241. [Abstract] J Clin Oncol 24 (Suppl 18): A-7058, 378s, 2006.
Results Reference
result
Citation
Langer C, Swann S, Werner-Wasik M, et al.: Phase I study of combination irinotecan and cisplatin and either twice daily thoracic radiation (45Gy) or once daily thoracic radiotherapy (70Gy) in patients with limited small cell lung carcinoma (SCLC): early toxicity analysis of RTOG 0241. [Abstract] Lung Cancer 49 (Suppl 2): A-P-777, S323, 2005.
Results Reference
result

Learn more about this trial

Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

We'll reach out to this number within 24 hrs