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Phase II Trial of Oral Topotecan and Paclitaxel With G-CSF (Filgrastim) Support in Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Trial of Oral Topotecan and Paclitaxel With G-CSF (Filgrastim) Support in Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

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

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study over 6 to 10

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

James R. Jett, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

November 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CentraCare ClinicSaint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080