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

Tracking Information

First Received Date ^ICMJE

March 3, 2005

Last Updated Date

November 25, 2008

Start Date ^ICMJE

June 2003

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Response

Change History

Complete list of historical versions of study NCT00104793 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Survival
Progression-free survival

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Drug: carboplatin
Drug: irinotecan hydrochloride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00104793

Responsible Party

Study ID Numbers ^ICMJE

CDR0000415703, JMTO-LC02-02

Study Sponsor ^ICMJE

Japan Multinational Trial Organization

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Tadashi Mio, MD

Kyoto University

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2007

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