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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
James R. Jett, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000069147
NCT ID:
NCT00028925
Start Date:
November 2001
Completion Date:
Related Keywords:
- Lung Cancer
- extensive stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| 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 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| 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 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
| MBCCOP-Howard University Cancer Center | Washington, District of Columbia 20060 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Medcenter One Health System | Bismarck, North Dakota 58501 |
| CentraCare Health Plaza | Saint Cloud, Minnesota 56303 |
| Wichita Community Clinical Oncology Program | Wichita, Kansas 67214-3882 |
