Clinical trial NCT00104793: Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer
Official title: Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-03-04
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving irinotecan together with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.

Detailed description: OBJECTIVES:

Primary

* Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin.

Secondary

* Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed small cell lung cancer

  * Extensive stage disease
* Newly diagnosed, treatment-naive disease
* At least 1 unidimensionally measurable lesion
* No massive pleural or pericardial effusion by chest CT scan

  * Manageable effusions allowed

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* ECOG 0-2

Life expectancy

* More than 3 months

Hematopoietic

* WBC ≥ 3,000/mm\^3
* Absolute granulocyte count ≥ 1,500/mm\^3
* Hemoglobin ≥ 9.0 g/dL

Hepatic

* ALT or AST ≤ 2 times upper limit of normal
* Bilirubin ≤ 1.5 mg/dL

Renal

* Creatinine normal

Cardiovascular

* No myocardial infarction within the past year
* No uncontrolled hypertension
* No unstable angina
* No congestive heart failure
* No ventricular arrhythmia requiring medical intervention
* No other serious cardiovascular disease

Pulmonary

* Arterial oxygen pressure (Pa O_2) ≥ 70 mm Hg
* No interstitial pneumonitis or pulmonary fibrosis by chest x-ray

Other

* Not pregnant or nursing
* No uncontrolled diabetes
* No severe infection
* No paralytic or obstructive ileus
* No serious diarrhea
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy to the chest

  * Other prior radiotherapy allowed

Surgery

* At least 2 weeks since prior surgery and recovered

Primary outcomes:
measure: Response
Secondary outcomes:
measure: Survival
measure: Progression-free survival
Other outcomes:
Locations:
city: Asahikawa
country: Japan
facility: National Hospital Organization - Dohoku National Hospital
state: Hokkaido
city: Fujisawa
country: Japan
facility: Fujisawa City Hospital
state: Kanagawa
city: Kurashiki-shi
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka General Medical Center
state: Osaka
city: Sakai
country: Japan
facility: National Hospital Organization - Osaka National Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Takatsuki Red Cross Hospital
state: Osaka
city: Yao
country: Japan
facility: Yao Tokusyu-kai General Hospital
state: Osaka
city: Gunma
country: Japan
facility: Gunma Cancer Center
city: Hiroshima
country: Japan
facility: National Hospital Organization - Medical Center of Kure
city: Osaka
country: Japan
facility: Osaka Kosei Nenkin Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
Study officials:
affiliation: Kyoto University Hospital
name: Tadashi Mio, MD
role: STUDY_CHAIR
References:
citation: Okishio K, Mio T, Kawahara M, Yoshioka H, Yanagihara K, Daimon T, Furuse K. A weekly combination of carboplatin and irinotecan for previously untreated extensive disease small-cell lung cancer, results of a minimum follow-up of 3 years: a multi-center Phase II trial JMTO LC02-02. Jpn J Clin Oncol. 2012 May;42(5):387-93. doi: 10.1093/jjco/hys028. Epub 2012 Mar 19.