Lung CancerPhase 2NCT00104793
Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing carboplatin and irinotecan hydrochloride in people with Lung Cancer, run by Japan Multinational Trial Organization at 11 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- carboplatin and irinotecan hydrochloride
- How many people
- 55 participants
- Where
- 11 sitesJapan
- Study dates
- Jun 2003to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
National Hospital Organization - Dohoku National Hospital
Asahikawa, Hokkaido, 070-0901
Fujisawa City Hospital
Fujisawa, Kanagawa, 251-8550
Gunma Cancer Center
Gunma, Gunma, 373-8550
National Hospital Organization - Medical Center of Kure
Hiroshima, 737-0023
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, 710-8602
Osaka Kosei Nenkin Hospital
Osaka, Osaka, 553-0003
Osaka General Medical Center
Osaka, Osaka, 558-0056
National Hospital Organization - Osaka National Hospital
Sakai, Osaka, 591-8555
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1096
Tokyo Medical and Dental University
Tokyo, Tokyo, 113-8519
Yao Tokusyu-kai General Hospital
Yao, Osaka, 561-0072
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, irinotecan hydrochloride
- Keywords
- extensive stage small cell lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Secondary outcomes (2)
Survival
Progression-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2005 (estimated)
- Study startJun 2003
- Primary completionFeb 2007
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japan Multinational Trial Organization
- Sponsor type
- University, hospital or other
- Investigators
- Tadashi Mio, MD, Study chair, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104793
- Sponsor's protocol ID
- JMTO-LC02-02
- Other IDs
- CDR0000415703
- Status last verified
- Oct 2007
- First submitted
- 3 Mar 2005
- Last updated
- 30 May 2013
- Results posted
- No
Publications
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.
PubMed 22430871
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00104793
- Acronym / sponsor ID
- JMTO-LC02-02
- Conditions
- Lung Cancer
- Keywords
- extensive stage small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Japan Multinational Trial OrganizationUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Feb 2007 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | – |
| irinotecan hydrochloride | Drug | – |
Primary outcome
Response
2 secondary outcomes
Survival
Progression-free survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
- Results publication: PubMed 22430871Okishio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadashi Mio, MD study chair
Kyoto University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin and irinotecan hydrochloride in people with Lung Cancer, run by Japan Multinational Trial Organization at 11 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00104793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.