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A Phase II Study of Irinotecan/Cisplatin Plus Simvastatin in Chemo-naive Patients With Extensive Disease-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Small Cell Lung Cancer

Thank you

Trial Information

A Phase II Study of Irinotecan/Cisplatin Plus Simvastatin in Chemo-naive Patients With Extensive Disease-Small Cell Lung Cancer

Cisplatin-30 mg/m2 on day 1 and 8 repeat q 3 weeks Irinotecan-65 mg/m2 on day1 and 8 repeat
q 3 weeks Simvastatin 40 mg per day orally from D1 of cycle 1

Treatment will be continued until disease progression, unacceptable toxicity, or patients'

Inclusion Criteria:

- Histologic or cytologic diagnosis of SCLC

- Extensive-stage disease, defined as disease extending beyond one hemithorax or
involving contralateral mediastinal, hilar or supraclavicular lymph nodes, and/or
pleural effusion.

- No prior chemotherapy, immunotherapy, or radiotherapy

- Performance status of 0, 1, 2 on the ECOG criteria.

- At least one unidimensional measurable lesion meeting Response Evaluation Criteria in
Solid Tumors (RECIST. 2000).

- Patient compliance that allow adequate follow-up.

- Adequate hematologic (WBC count ≥ 4,000/mm3, platelet count ≥ 150,000/mm3), hepatic
(bilirubin level ≤ 1.5 mg/dL, AST/ALT ≤ 80 IU/L), and renal (creatinine concentration
≤ 1.5 mg/dL) function.

- Informed consent from patient or patient's relative.

- Males or females at least 18 years of age.

- If female: childbearing potential either terminated by surgery, radiation, or
menopause, or attenuated by use of an approved contraceptive method (intrauterine
device [IUD], birth control pills, or barrier device) during and for 3 months after
trial. If male, use of an approved contraceptive method during the study and 3 months
afterwards. Females with childbearing potential must have a urine negative HCG test
within 7 days prior to the study enrollment.

- No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital,
phenytoin, ketoconazole.

- Patients with brain metastasis are allowed unless there were clinically significant
neurological symptoms or signs

Exclusion Criteria:

- Inability to comply with protocol or study procedures.

- A serious concomitant systemic disorder that, in the opinion of the investigator,
would compromise the patient's ability to complete the study.

- A serious cardiac condition, such as myocardial infarction within 6 months, angina,
or heart disease, as defined by the New York Heart Association Class III or IV.

- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment.

- Concurrent administration of any other antitumor therapy.

- Pregnant or breast-feeding.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1-year survival & overall survival

Outcome Time Frame:

the first day of treatment to death or last survival confirm date

Safety Issue:


Principal Investigator

Ji-Youn Han, M.D.,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

April 2006

Completion Date:

May 2010

Related Keywords:

  • Small Cell Lung Cancer
  • Irinotecan
  • cisplatin
  • Simvastatin
  • Extensive disease
  • SCLC
  • Lung Neoplasms
  • Small Cell Lung Carcinoma