Lung CancerPhase 1NCT00132054
Amrubicin and Irinotecan in Treating Patients With Recurrent or Relapsed Extensive Stage Small Cell Lung Cancer
A Phase 1 study testing amrubicin hydrochloride and irinotecan hydrochloride in people with Lung Cancer, run by Japan Multinational Trial Organization at 7 sites in Japan.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as amrubicin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) 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?
- amrubicin hydrochloride and irinotecan hydrochloride
- How many people
- 30 participants
- Where
- 7 sitesJapan
- Study dates
- May 2004to Nov 2008
- Phase
- Phase 1
- 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
- Recurrent or relapsed disease after 1-2 prior chemotherapy and/or radiotherapy regimens
- No unmanageable massive pleural effusion or pericardial effusion by chest CT scan
- No symptomatic brain metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 3 months
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.5 g/dL
Hepatic
- ALT and AST ≤ 2 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
Renal
- Creatinine normal
Cardiovascular
- No uncontrolled hypertension
- No unstable angina
- No congestive heart failure
- No myocardial infarction within the past year
- No ventricular arrhythmia requiring medical intervention
- No other serious cardiovascular disease
Pulmonary
- Arterial oxygen pressure (PaO_2) ≥ 70 torr
- No interstitial pneumonitis or pulmonary fibrosis by chest x-ray
Gastrointestinal
- No serious diarrhea
- No paralytic or obstructive ileus
Other
- Not pregnant or nursing
- No uncontrolled diabetes
- No severe infectious disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No prior anthracycline or its derivatives at > the upper dose limit (e.g., daunorubicin ≥ 25 mg/kg, doxorubicin ≥ 500 mg/m^2, or epirubicin ≥ 900 mg/m^2)
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Gunma Cancer Center
Gunma, 373-0828
National Hospital Organization - Dohoku National Hospital
Hokkaido, 070-0901
Kyoto University Hospital
Kyoto, 606-8501
Kitano Hospital
Osaka, 530-8480
Osaka Police Hospital
Osaka, 543-0035
Osaka Kosei Nenkin Hospital
Osaka, 553-0003
National Hospital Organization - Osaka National Hospital
Osaka, 591-8555
About this study
Official title: Phase I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as amrubicin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of amrubicin when given together with irinotecan in treating patients with recurrent or relapsed extensive stage small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of amrubicin when combined with irinotecan in patients with recurrent or relapsed extensive stage small cell lung cancer.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the frequency and severity of adverse events in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of amrubicin.
Patients receive amrubicin on day 1 and irinotecan IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 6 patients receive escalating doses of amrubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1/3 (or 33%) of patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 6-30 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- amrubicin hydrochloride, irinotecan hydrochloride
- Keywords
- extensive stage small cell lung cancer, recurrent small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amrubicin hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startMay 2004
- Primary completionDec 2006
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Enrolment
- 30 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
- NCT00132054
- Sponsor's protocol ID
- JMTO-LC03-03
- Other IDs
- CDR0000439464
- Status last verified
- Dec 2006
- First submitted
- 16 Aug 2005
- Last updated
- 30 May 2013
- Results posted
- No
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 I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00132054
- Acronym / sponsor ID
- JMTO-LC03-03
- Conditions
- Lung Cancer
- Keywords
- extensive stage small cell lung cancer, recurrent small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Japan Multinational Trial OrganizationUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 19 Aug 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 amrubicin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of amrubicin when given together with irinotecan in treating patients with recurrent or relapsed extensive stage small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of amrubicin when combined with irinotecan in patients with recurrent or relapsed extensive stage small cell lung cancer.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the frequency and severity of adverse events in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of amrubicin.
Patients receive amrubicin on day 1 and irinotecan IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 6 patients receive escalating doses of amrubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1/3 (or 33%) of patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 6-30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| amrubicin hydrochloride | Drug | – |
| irinotecan hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing amrubicin hydrochloride and irinotecan hydrochloride in people with Lung Cancer, run by Japan Multinational Trial Organization at 7 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 7 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
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.