Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2001
End Date:August 2008

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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

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 compare the effectiveness of combination chemotherapy with or
without filgrastim in treating patients who have extensive-stage small cell lung cancer that
has not been previously treated.

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.

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
We found this trial at
24
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509 W. University Avenue
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(217) 383-3516
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Ann Arbor, Michigan 48106
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Bismarck, North Dakota 58501
1006
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Cedar Rapids, Iowa 52403
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
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565
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Fargo, North Dakota 58122
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Grand Forks, North Dakota 58201
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352
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320 E North Ave
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Regina, Saskatchewan
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Saint Cloud, Minnesota 56303
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Saint Louis Park, Minnesota 55416
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Scottsdale, Arizona 85259
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