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Topotecan, Paclitaxel, and Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
paclitaxel
topotecan hydrochloride
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 previously untreated small cell lung cancer No mixed histology Extensive disease Metastatic disease outside the chest Contralateral supraclavicular nodes or contralateral hilar nodes outside a single radiation port OR Cytologically proven malignant pleural effusion Measurable or evaluable disease No untreated CNS metastases CNS metastases previously treated with whole brain radiotherapy allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Total bilirubin no greater than 1.5 times ULN OR Direct bilirubin normal Renal: Creatinine no greater than 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 greater than 40% No uncontrolled arrhythmias No myocardial infarction within the past 3 months Other: No significant infection No hypersensitivity to E. coli derivatives No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 10 years since prior chemotherapy No prior nitrosourea based chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 10 years since prior thoracic radiotherapy No more than 3 fractions of prior thoracic radiotherapy for superior vena cava syndrome Prior palliative radiotherapy except to the chest allowed No prior radiotherapy to at least 20% bone marrow No concurrent radiotherapy (including thoracic), except whole brain radiotherapy for CNS progression Surgery: At least 3 weeks since prior major surgery

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • Siouxland Hematology-Oncology
  • CCOP - Wichita
  • CCOP - Duluth
  • Mayo Clinic Cancer Center
  • CentraCare Clinic
  • CCOP - Metro-Minnesota
  • CCOP - Missouri Valley Cancer Consortium
  • Quain & Ramstad Clinic, P.C.
  • CCOP - Merit Care Hospital
  • Altru Health Systems
  • CCOP - Toledo Community Hospital Oncology Program
  • CCOP - Geisinger Clinical and Medical Center
  • Rapid City Regional Hospital
  • CCOP - Sioux Community Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

topotecan + paclitaxel + filgrastim

Arm Description

Patients receive oral topotecan on days 1-5 followed by paclitaxel IV over 3 hours on day 5. Beginning 24-48 hours after chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily for up to 10 days until blood counts recover. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression. Patients who develop CNS progressive disease only should receive whole brain radiotherapy before continuing study treatment.

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

survival

Full Information

First Posted
December 10, 1999
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004055
Brief Title
Topotecan, Paclitaxel, and Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
Official Title
Phase II Trial of Oral Topotecan and Paclitaxel With G-CSF (Filgrastim) Support in Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (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 study the effectiveness of topotecan, paclitaxel, and filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.
Detailed Description
OBJECTIVES: I. Evaluate oral topotecan and paclitaxel in terms of toxicity and complete and partial response rate in patients with previously untreated extensive stage small cell lung cancer. II. Determine preliminary estimates of survival in this patient population in response to this regimen. OUTLINE: Patients receive oral topotecan on days 1-5 followed by paclitaxel IV over 3 hours on day 5. Beginning 24-48 hours after chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily for up to 10 days until blood counts recover. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression. Patients who develop CNS progressive disease only should receive whole brain radiotherapy before continuing study treatment.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
topotecan + paclitaxel + filgrastim
Arm Type
Experimental
Arm Description
Patients receive oral topotecan on days 1-5 followed by paclitaxel IV over 3 hours on day 5. Beginning 24-48 hours after chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily for up to 10 days until blood counts recover. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression. Patients who develop CNS progressive disease only should receive whole brain radiotherapy before continuing study treatment.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Primary Outcome Measure Information:
Title
response rate
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
survival
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed previously untreated small cell lung cancer No mixed histology Extensive disease Metastatic disease outside the chest Contralateral supraclavicular nodes or contralateral hilar nodes outside a single radiation port OR Cytologically proven malignant pleural effusion Measurable or evaluable disease No untreated CNS metastases CNS metastases previously treated with whole brain radiotherapy allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Total bilirubin no greater than 1.5 times ULN OR Direct bilirubin normal Renal: Creatinine no greater than 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 greater than 40% No uncontrolled arrhythmias No myocardial infarction within the past 3 months Other: No significant infection No hypersensitivity to E. coli derivatives No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 10 years since prior chemotherapy No prior nitrosourea based chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 10 years since prior thoracic radiotherapy No more than 3 fractions of prior thoracic radiotherapy for superior vena cava syndrome Prior palliative radiotherapy except to the chest allowed No prior radiotherapy to at least 20% bone marrow No concurrent radiotherapy (including thoracic), except whole brain radiotherapy for CNS progression Surgery: At least 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
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
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 Clinic
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
68131
Country
United States
Facility Name
Quain & Ramstad Clinic, P.C.
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
CCOP - Geisinger Clinical and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
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
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105-1080
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20960500
Citation
Foster NR, Qi Y, Shi Q, Krook JE, Kugler JW, Jett JR, Molina JR, Schild SE, Adjei AA, Mandrekar SJ. Tumor response and progression-free survival as potential surrogate endpoints for overall survival in extensive stage small-cell lung cancer: findings on the basis of North Central Cancer Treatment Group trials. Cancer. 2011 Mar 15;117(6):1262-71. doi: 10.1002/cncr.25526. Epub 2010 Oct 19.
Results Reference
background
PubMed Identifier
16755177
Citation
Molina JR, Jett JR, Foster N, Lair BS, Carroll TJ, Tazelaar HD, Hillman S, Mailliard JA, Bernath AM Jr, Nikcevich D. Phase II NCCTG trial of oral topotecan and paclitaxel with G-CSF (filgrastim) support in patients with previously untreated extensive-stage small cell lung cancer. Am J Clin Oncol. 2006 Jun;29(3):246-51. doi: 10.1097/01.coc.0000217566.11742.b5.
Results Reference
result
Citation
Jett JR, Bernath AM Jr, Hillman SL, et al.: Oral topotecan and paclitaxel with G-CSF support in patients with untreated extensive stage small cell (ED-SCLC): a phase II trial of the NCCTG. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1301, 2002.
Results Reference
result

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Topotecan, Paclitaxel, and Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

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