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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Irinotecan U 101440E Irinotecan hydrochloride

U.S. FDA Resources

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
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000415703, JMTO-LC02-02
Study First Received:	March 3, 2005
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00104793 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

extensive stage small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Irinotecan
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Respiratory Tract Neoplasms
Neoplasms by Histologic Type

Enzyme Inhibitors
Carboplatin
Camptothecin
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Lung Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009