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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00104793
First received: March 3, 2005
Last updated: May 29, 2013
Last verified: October 2007

March 3, 2005
May 29, 2013
June 2003
February 2007   (final data collection date for primary outcome measure)
Response [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00104793 on ClinicalTrials.gov Archive Site
  • Survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: carboplatin
  • Drug: irinotecan hydrochloride
Not Provided
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 Mar 19. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
November 2008
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00104793
JMTO-LC02-02, CDR0000415703
Not Provided
Not Provided
Japan Multinational Trial Organization
Not Provided
Study Chair: Tadashi Mio, MD Kyoto University
National Cancer Institute (NCI)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP