Phase II Trial of Topotecan and Paclitaxel in Previously Treated Patients With Relapsed Small Cell Lung Cancer
- Determine the toxicity of combination topotecan and paclitaxel in previously treated
patients with small cell lung cancer.
- Determine the response rate and survival in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time
since prior treatment (less than 3 months (stratum A) vs 3 months or more (stratum B)).
Stratum A closed to accrual effective 06/20/2000.
Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on
day 3. Courses repeat every 4 weeks.
Patients who achieve partial response or stable disease continue treatment in the absence of
complete response or disease progression. Patients who develop disease progression in the
CNS only should receive whole brain radiotherapy and then continue treatment. Patients who
achieve complete remission receive a maximum of 6 courses of treatment. Patients may then
undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at
the attending physician.
Patients are followed every 3 months for 2 years and then at 3 years after study.
PROJECTED ACCRUAL: A total of 19-55 patients will be accrued for stratum B of this study
over 12-21 months. Stratum A closed to accrual effective 06/20/2000.
Primary Purpose: Treatment
James R. Jett, MD
United States: Federal Government
|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 - 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|
|CCOP - Ochsner||New Orleans, Louisiana 70121|
|Altru Health Systems||Grand Forks, North Dakota 58201|
|CCOP - Toledo Community Hospital Oncology Program||Toledo, Ohio 43623-3456|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|CentraCare Health Plaza||Saint Cloud, Minnesota 56303|