Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

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 CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
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
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
MBCCOP-Howard University Cancer CenterWashington, District of Columbia  20060
Mayo ClinicJacksonville, Florida  32224
Medcenter One Health SystemBismarck, North Dakota  58501
CentraCare Health PlazaSaint Cloud, Minnesota  56303
Wichita Community Clinical Oncology ProgramWichita, Kansas  67214-3882