Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer

Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: carboplatin; Drug: irinotecan hydrochloride

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.

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Gunma, Japan, 373-8550
    • Gunma Cancer Center
  • Hiroshima, Japan, 737-0023
    • National Hospital Organization - Medical Center of Kure
  • Osaka, Japan, 553-0003
    • Osaka Kosei Nenkin Hospital
  • Tokyo, Japan, 113-8519
    • Tokyo Medical and Dental University
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-0901
      • National Hospital Organization - Dohoku National Hospital
  • Kanagawa
    • Fujisawa, Kanagawa, Japan, 251-8550
      • Fujisawa City Hospital
  • Okayama
    • Kurashiki-shi, Okayama, Japan, 710-8602
      • Kurashiki Central Hospital
  • Osaka
    • Osaka-shi, Osaka, Japan, 558-0056
      • Osaka General Medical Center
    • Sakai, Osaka, Japan, 591-8555
      • National Hospital Organization - Osaka National Hospital
    • Takatsuki, Osaka, Japan, 569-1096
      • Takatsuki Red Cross Hospital
    • Yao, Osaka, Japan, 561-0072
      • Yao Tokusyu-kai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Survival

Collaborators and Investigators

• Sponsor: Japan Multinational Trial Organization
• Investigators: Study Chair: Tadashi Mio, MD, Kyoto University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: March 3, 2005
• First Submitted That Met QC Criteria: March 3, 2005
• First Posted (Estimate): March 4, 2005

Study Record Updates

• Last Update Posted (Estimate): May 30, 2013
• Last Update Submitted That Met QC Criteria: May 29, 2013
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: extensive stage small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Carboplatin; Irinotecan
• Other Study ID Numbers: JMTO-LC02-02; CDR0000415703 (Registry Identifier: PDQ (Physician Data Query))