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

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: irinotecan hydrochloride	Phase II

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Carboplatin Irinotecan Irinotecan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	55
Study Start Date:	June 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104793

Locations


Japan
	National Hospital Organization - Medical Center of Kure
	Hiroshima, Japan, 737-0023
	Gunma Cancer Center
	Gunma, Japan, 373-8550
	Osaka Kosei Nenkin Hospital
	Osaka, Japan, 553-0003
	Tokyo Medical and Dental University
	Tokyo, Japan, 113-8519

Japan, Hokkaido
	National Hospital Organization - Dohoku National Hospital
	Asahikawa, Hokkaido, Japan, 070-0901

Japan, Kanagawa
	Fujisawa City Hospital
	Fujisawa, Kanagawa, Japan, 251-8550

Japan, Okayama
	Kurashiki Central Hospital
	Kurashiki-shi, Okayama, Japan, 710-8602

Japan, Osaka
	National Hospital Organization - Osaka National Hospital
	Sakai, Osaka, Japan, 591-8555
	Osaka General Medical Center
	Osaka-shi, Osaka, Japan, 558-0056
	Takatsuki Red Cross Hospital
	Takatsuki, Osaka, Japan, 569-1096
	Yao Tokusyu-kai General Hospital
	Yao, Osaka, Japan, 561-0072

Sponsors and Collaborators

Japan Multinational Trial Organization

Investigators


Study Chair:	Tadashi Mio, MD	Kyoto University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000415703, JMTO-LC02-02
First Received:	March 3, 2005
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00104793
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

extensive stage small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms

Carcinoma, Neuroendocrine

Irinotecan

Carboplatin

Camptothecin

Carcinoma

Neuroendocrine Tumors

Carcinoma, Small Cell

Neuroectodermal Tumors

Lung Neoplasms

Lung Diseases

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Respiratory Tract Diseases

Antineoplastic Agents

Therapeutic Uses

Neoplasms, Nerve Tissue

Enzyme Inhibitors

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	Japan Multinational Trial Organization
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00104793