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
treatment.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study over 6 to 10
months.
Interventional
Primary Purpose: Treatment
James R. Jett, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000067251
NCT00004055
November 1999
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Altru Health Systems | Grand Forks, North Dakota 58201 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |