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Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
filgrastim
carboplatin
topotecan hydrochloride
WBRT
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 extensive 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 extensive stage small cell lung cancer Previously untreated with chemotherapy No mixed histology Metastatic disease outside the chest Contralateral supraclavicular or hilar nodes that cannot be included in a single radiation port OR Cytologically proven malignant pleural effusion Measurable disease No untreated CNS metastases CNS metastases treated with whole-brain radiotherapy (WBRT) allowed after completion of WBRT PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: AST no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Bilirubin no greater than 1.5 times ULN OR Direct bilirubin no greater than ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 50 mL/min Cardiovascular: No uncontrolled angina pectoris No congestive heart failure within the past 3 months unless ejection fraction is greater than 40% No uncontrolled cardiac arrhythmias No myocardial infarction within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No clinically significant infection No hypersensitivity to E. coli-derived proteins No other malignancy within the past 3 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 5 years since prior chemotherapy for another malignancy No prior nitrosoureas Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior thoracic radiotherapy At least 1 day since prior palliative radiotherapy (except to chest) No more than 3 fractions to chest for superior vena cava syndrome allowed No concurrent radiotherapy (including thoracic radiotherapy) Surgery: More than 3 weeks since prior major surgery

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • MBCCOP-Howard University Cancer Center
  • Mayo Clinic
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • Siouxland Hematology-Oncology
  • CCOP - Wichita
  • Wichita Community Clinical Oncology Program
  • CCOP - Ochsner
  • CCOP - Ann Arbor Regional
  • CCOP - Duluth
  • Mayo Clinic Cancer Center
  • CentraCare Health Plaza
  • CCOP - Metro-Minnesota
  • CCOP - Missouri Valley Cancer Consortium
  • Medcenter One Health System
  • CCOP - Merit Care Hospital
  • Altru Health Systems
  • CCOP - Toledo Community Hospital Oncology Program
  • Allegheny General Hospital
  • Rapid City Regional Hospital
  • Allan Blair Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Regimen A

Regimen B

Arm Description

Patients receive oral topotecan once daily on days 1-5, carboplatin IV over 30 minutes on day 5, and filgrastim (G-CSF) subcutaneously once daily beginning on day 6 or 7 and continuing for up to 10 days or until blood counts recover. Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes. Quality of life is assessed at baseline and at the beginning of each course of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Patients receive topotecan and carboplatin as in regimen A. Patients are evaluated after the first 3-week course of chemotherapy. If no patient experiences unacceptable toxicity or febrile neutropenia, the next 33 patients receive treatment as in regimen B; otherwise, patients receive treatment as in regimen A. Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes. Quality of life is assessed at baseline and at the beginning of each course of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

overall survival

Full Information

First Posted
January 4, 2002
Last Updated
December 5, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00028925
Brief Title
Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
Official Title
Phase II Trial of Oral Topotecan and Intravenous Carboplatin With G-CSF (Filgrastim) Support in Previously Untreated Patients With Extensive Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
August 2008 (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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without filgrastim in treating patients who have extensive-stage small cell lung cancer that has not been previously treated.
Detailed Description
OBJECTIVES: Determine the tolerability of topotecan and carboplatin with or without filgrastim (G-CSF) in patients with extensive stage small cell lung cancer. Determine response and survival rates in patients treated with these regimens. OUTLINE: This is a multicenter study. The first 12 patients are assigned to 1 of 2 treatment regimens (6 per regimen). The next 33 patients receive treatment based on the toxicity experienced by the first 12. Regimen A: Patients receive oral topotecan once daily on days 1-5, carboplatin IV over 30 minutes on day 5, and filgrastim (G-CSF) subcutaneously once daily beginning on day 6 or 7 and continuing for up to 10 days or until blood counts recover. Patients are evaluated after the first 3-week course of chemotherapy. If no patient experiences unacceptable toxicity or febrile neutropenia, or no more than 1 patient experiences an absolute neutrophil count of less than 500/mm3 for more than 5 days, the next 6 patients begin treatment on regimen B. Otherwise, all patients receive treatment as in regimen A. Regimen B: Patients receive topotecan and carboplatin as in regimen A. Patients are evaluated after the first 3-week course of chemotherapy. If no patient experiences unacceptable toxicity or febrile neutropenia, the next 33 patients receive treatment as in regimen B; otherwise, patients receive treatment as in regimen A. Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes. Quality of life is assessed at baseline and at the beginning of each course of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 49 patients will be accrued for this study within 13.5 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen A
Arm Type
Experimental
Arm Description
Patients receive oral topotecan once daily on days 1-5, carboplatin IV over 30 minutes on day 5, and filgrastim (G-CSF) subcutaneously once daily beginning on day 6 or 7 and continuing for up to 10 days or until blood counts recover. Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes. Quality of life is assessed at baseline and at the beginning of each course of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Arm Title
Regimen B
Arm Type
Experimental
Arm Description
Patients receive topotecan and carboplatin as in regimen A. Patients are evaluated after the first 3-week course of chemotherapy. If no patient experiences unacceptable toxicity or febrile neutropenia, the next 33 patients receive treatment as in regimen B; otherwise, patients receive treatment as in regimen A. Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes. Quality of life is assessed at baseline and at the beginning of each course of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Intervention Type
Radiation
Intervention Name(s)
WBRT
Primary Outcome Measure Information:
Title
response rate
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed extensive stage small cell lung cancer Previously untreated with chemotherapy No mixed histology Metastatic disease outside the chest Contralateral supraclavicular or hilar nodes that cannot be included in a single radiation port OR Cytologically proven malignant pleural effusion Measurable disease No untreated CNS metastases CNS metastases treated with whole-brain radiotherapy (WBRT) allowed after completion of WBRT PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: AST no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Bilirubin no greater than 1.5 times ULN OR Direct bilirubin no greater than ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 50 mL/min Cardiovascular: No uncontrolled angina pectoris No congestive heart failure within the past 3 months unless ejection fraction is greater than 40% No uncontrolled cardiac arrhythmias No myocardial infarction within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No clinically significant infection No hypersensitivity to E. coli-derived proteins No other malignancy within the past 3 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 5 years since prior chemotherapy for another malignancy No prior nitrosoureas Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior thoracic radiotherapy At least 1 day since prior palliative radiotherapy (except to chest) No more than 3 fractions to chest for superior vena cava syndrome allowed No concurrent radiotherapy (including thoracic radiotherapy) Surgery: More than 3 weeks since prior major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R. Jett, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
MBCCOP-Howard University Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
Siouxland Hematology-Oncology
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
Wichita Community Clinical Oncology Program
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CentraCare Health Plaza
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Medcenter One Health System
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Altru Health Systems
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4772
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57709
Country
United States
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19935387
Citation
Bryce AH, Mattar B, Hillman SL, Adjei AA, Kugler JW, Rowland K Jr, Wender DB, Soori G, Perez EA, Jett JR. Phase II trial of oral topotecan and intravenous carboplatin with G-CSF support in previously untreated patients with extensive stage small cell lung cancer: A North Central Cancer Treatment Group Study. Am J Clin Oncol. 2010 Aug;33(4):353-7. doi: 10.1097/COC.0b013e3181b0c27f.
Results Reference
result

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Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

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