NCT00104793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started Jun 2003

Typical duration for phase_2 lung-cancer

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

May 30, 2013

Status Verified

October 1, 2007

Enrollment Period

3.7 years

First QC Date

March 3, 2005

Last Update Submit

May 29, 2013

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Response

Secondary Outcomes (2)

  • Survival

  • Progression-free survival

Interventions

carboplatinDRUG
irinotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

Gunma Cancer Center

Gunma, Gunma, 373-8550, Japan

Location

National Hospital Organization - Dohoku National Hospital

Asahikawa, Hokkaido, 070-0901, Japan

Location

Fujisawa City Hospital

Fujisawa, Kanagawa, 251-8550, Japan

Location

Kurashiki Central Hospital

Kurashiki-shi, Okayama-ken, 710-8602, Japan

Location

Osaka Kosei Nenkin Hospital

Osaka, Osaka, 553-0003, Japan

Location

Osaka General Medical Center

Osaka, Osaka, 558-0056, Japan

Location

National Hospital Organization - Osaka National Hospital

Sakai, Osaka, 591-8555, Japan

Location

Takatsuki Red Cross Hospital

Takatsuki, Osaka, 569-1096, Japan

Location

Yao Tokusyu-kai General Hospital

Yao, Osaka, 561-0072, Japan

Location

Tokyo Medical and Dental University

Tokyo, Tokyo, 113-8519, Japan

Location

National Hospital Organization - Medical Center of Kure

Hiroshima, 737-0023, Japan

Location

Related Publications (1)

  • 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.

    PMID: 22430871RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

CarboplatinIrinotecan

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Tadashi Mio, MD

    Kyoto University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2005

First Posted

March 4, 2005

Study Start

June 1, 2003

Primary Completion

February 1, 2007

Study Completion

November 1, 2008

Last Updated

May 30, 2013

Record last verified: 2007-10

Locations

JP(11)