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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
carboplatin
etoposide
paclitaxel
topotecan hydrochloride
radiation therapy
Sponsored by
Alliance for Clinical Trials in Oncology
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 - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer Limited stage defined as disease restricted to one hemithorax with regional lymph node metastases including hilar, ipsilateral, and contralateral mediastinal lymph nodes Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Lesions not considered measurable include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Tumor lesions in a previously irradiated area No clinically suspected or confirmed supraclavicular lymph node metastases No pleural effusions visible on plain chest radiographs, regardless of cytology PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,00/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than ULN Creatinine clearance no greater than 150 mL/min for men or 130 mL/min for women Other: Not pregnant or nursing Fertile patients must use effective contraception No other currently active malignancy except non-melanoma skin cancer Patients must have completed therapy for any other malignancy and be considered to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) during consolidation therapy Chemotherapy: No prior chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except: Steroids for adrenal failure Hormones for non-disease-related conditions (e.g., insulin for diabetes) Intermittent use of dexamethasone as an antiemetic or as an adjunct to prophylactic cranial irradiation Radiotherapy: See Disease Characteristics No prior chest radiotherapy Surgery: Not specified

Sites / Locations

  • Veterans Affairs Medical Center - Birmingham
  • University of California San Diego Cancer Center
  • Cedars-Sinai Medical Center
  • Veterans Affairs Medical Center - San Francisco
  • UCSF Cancer Center and Cancer Research Institute
  • CCOP - Christiana Care Health Services
  • Lombardi Cancer Center
  • Walter Reed Army Medical Center
  • CCOP - Mount Sinai Medical Center
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
  • University of Chicago Cancer Research Center
  • CCOP - Northern Indiana CR Consortium
  • Holden Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Togus
  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  • Dana-Farber Cancer Institute
  • University of Massachusetts Memorial Medical Center - University Campus
  • Veterans Affairs Medical Center - Minneapolis
  • University of Minnesota Cancer Center
  • Veterans Affairs Medical Center - Columbia (Truman Memorial)
  • Ellis Fischel Cancer Center - Columbia
  • Barnes-Jewish Hospital
  • Missouri Baptist Cancer Center
  • University of Nebraska Medical Center
  • CCOP - Southern Nevada Cancer Research Foundation
  • Norris Cotton Cancer Center
  • Veterans Affairs Medical Center - Buffalo
  • Roswell Park Cancer Institute
  • CCOP - North Shore University Hospital
  • North Shore University Hospital
  • Memorial Sloan-Kettering Cancer Center
  • New York Presbyterian Hospital - Cornell Campus
  • Mount Sinai Medical Center, NY
  • State University of New York - Upstate Medical University
  • Veterans Affairs Medical Center - Syracuse
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • Lineberger Comprehensive Cancer Center, UNC
  • Veterans Affairs Medical Center - Durham
  • Duke Comprehensive Cancer Center
  • CCOP - Southeast Cancer Control Consortium
  • Comprehensive Cancer Center at Wake Forest University
  • Arthur G. James Cancer Hospital - Ohio State University
  • Western Pennsylvania Hospital
  • Rhode Island Hospital
  • University of Tennessee Cancer Institute
  • Veterans Affairs Medical Center - Memphis
  • Green Mountain Oncology Group
  • Vermont Cancer Center
  • Veterans Affairs Medical Center - White River Junction
  • Veterans Affairs Medical Center - Richmond
  • MBCCOP - Massey Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemotherapy + radiation therapy

Arm Description

Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Outcomes

Primary Outcome Measures

overall response rate

Secondary Outcome Measures

failure-free survival
overall survival

Full Information

First Posted
April 9, 2002
Last Updated
July 15, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00033696
Brief Title
Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Official Title
Paclitaxel/Topotecan/Etoposide (EtopoTax) Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

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 and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.
Detailed Description
OBJECTIVES: Determine the complete and overall response rates in patients with limited stage small cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan, and etoposide followed by consolidation chemoradiotherapy. Determine the toxicity of this regimen in these patients. Determine the overall and failure-free survival of patients treated with this regimen. Determine the overall (partial and complete) response rate in patients treated with this induction chemotherapy regimen. OUTLINE: This is a multicenter study. Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10 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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chemotherapy + radiation therapy
Arm Type
Experimental
Arm Description
Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
failure-free survival
Time Frame
up to 5 years
Title
overall survival
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer Limited stage defined as disease restricted to one hemithorax with regional lymph node metastases including hilar, ipsilateral, and contralateral mediastinal lymph nodes Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Lesions not considered measurable include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Tumor lesions in a previously irradiated area No clinically suspected or confirmed supraclavicular lymph node metastases No pleural effusions visible on plain chest radiographs, regardless of cytology PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,00/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than ULN Creatinine clearance no greater than 150 mL/min for men or 130 mL/min for women Other: Not pregnant or nursing Fertile patients must use effective contraception No other currently active malignancy except non-melanoma skin cancer Patients must have completed therapy for any other malignancy and be considered to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) during consolidation therapy Chemotherapy: No prior chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except: Steroids for adrenal failure Hormones for non-disease-related conditions (e.g., insulin for diabetes) Intermittent use of dexamethasone as an antiemetic or as an adjunct to prophylactic cranial irradiation Radiotherapy: See Disease Characteristics No prior chest radiotherapy Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonius A. Miller, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Affairs Medical Center - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1996
Country
United States
Facility Name
University of California San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Veterans Affairs Medical Center - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
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
Veterans Affairs Medical Center - Chicago (Westside Hospital)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
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
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Veterans Affairs Medical Center - Togus
City
Togus
State/Province
Maine
ZIP/Postal Code
04330
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Veterans Affairs Medical Center - Columbia (Truman Memorial)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Veterans Affairs Medical Center - Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Presbyterian Hospital - Cornell Campus
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13217
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104-4241
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of Tennessee Cancer Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Veterans Affairs Medical Center - Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Green Mountain Oncology Group
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
Veterans Affairs Medical Center - White River Junction
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Facility Name
Veterans Affairs Medical Center - Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
MBCCOP - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17607121
Citation
Miller AA, Wang XF, Bogart JA, Hodgson LD, Rocha Lima CM, Radford JE, Vokes EE, Green MR; Cancer and Leukemia Group B (CALGB). Phase II trial of paclitaxel-topotecan-etoposide followed by consolidation chemoradiotherapy for limited-stage small cell lung cancer: CALGB 30002. J Thorac Oncol. 2007 Jul;2(7):645-51. doi: 10.1097/JTO.0b013e318074bbf5.
Results Reference
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Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

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