Lung CancerPhase 2NCT00754858
Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing belotecan hydrochloride and cisplatin in people with Lung Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- belotecan hydrochloride and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2008to Jun 2012
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed small cell lung cancer meeting the following criteria:
- Extensive-stage disease
- Previously untreated disease
- At least one measurable disease
- No brain or leptomeningeal metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 mg/dL
- ALT and AST ≤ 2.0 times upper normal limit (ULN) (≤ 5.0 times ULN in the presence of liver metastasis)
- Alkaline phosphatase ≤ 2.0 times ULN
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- No active infection requiring intravenous antibiotics
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or in situ cancer
- No other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, interfere with the interpretation of study results, or make the patient ineligible for study entry, in the judgment of the investigator
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No other concurrent chemotherapy, radiotherapy, or immunotherapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, 120-752
About this study
Official title: Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving belotecan together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well belotecan works when given together with cisplatin in treating patients with previously untreated extensive stage small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To assess the antitumor efficacy, in terms of objective response rate, of belotecan hydrochloride and cisplatin in patients with previously untreated extensive-stage small cell lung cancer.
Secondary
- To assess additional evidence of antitumor activity as measured by overall and progression-free survival of these patients.
- To determine the safety and tolerability of this drug combination in these patients.
OUTLINE: Patients receive cisplatin IV on day 1 and belotecan hydrochloride IV on days 2-4.Treatment continues in the absence of disease progression or unacceptable toxicity.
- Conditions
- Lung Cancer
- Being tested
- belotecan hydrochloride, cisplatin
- 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.
belotecan hydrochlorideDrug
cisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| belotecan and Cisplatin | Experimental | belotecan 0.5 mg/m2 and Cisplatin 60mg/m2 Receives: Drug: belotecan hydrochloride; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate as assessed by RECIST criteria
Measured: 21days(1cycle)
Overall survival
Measured: 21days(1cycle)
Progression-free survival
Measured: 21days(1cycle)
Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0
Measured: 21days(1cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2010
- Study completionJun 2012
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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joo-Hang Kim, MD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754858
- Sponsor's protocol ID
- CDR0000614308
- Other IDs
- YONSEI-4-2008-0127, CKDPC-YONSEI-4-2008-0127, YONSEI-07-YUHS-02
- Status last verified
- Nov 2014
- First submitted
- 17 Sep 2008
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00754858
- Acronym / sponsor ID
- CDR0000614308
- Conditions
- Lung Cancer
- Keywords
- extensive stage small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Sep 2008 (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 cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving belotecan together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well belotecan works when given together with cisplatin in treating patients with previously untreated extensive stage small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- To assess the antitumor efficacy, in terms of objective response rate, of belotecan hydrochloride and cisplatin in patients with previously untreated extensive-stage small cell lung cancer.
Secondary
- To assess additional evidence of antitumor activity as measured by overall and progression-free survival of these patients.
- To determine the safety and tolerability of this drug combination in these patients.
OUTLINE: Patients receive cisplatin IV on day 1 and belotecan hydrochloride IV on days 2-4.Treatment continues in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| belotecan and Cisplatin | Experimental | Drug: belotecan hydrochloride, Drug: cisplatinbelotecan 0.5 mg/m2 and Cisplatin 60mg/m2 |
Who may qualify
- Ages
- 18 to 75 years
- 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 |
|---|---|---|
| belotecan hydrochloride | Drug | belotecan and Cisplatin |
| cisplatin | Drug | belotecan and Cisplatin |
Primary outcome
Response rate as assessed by RECIST criteria
Time frame: 21days(1cycle)
Overall survival
Time frame: 21days(1cycle)
Progression-free survival
Time frame: 21days(1cycle)
Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0
Time frame: 21days(1cycle)
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 2 Dec 2014.
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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.
Joo-Hang Kim, MD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing belotecan hydrochloride and cisplatin in people with Lung Cancer, run by Yonsei University at 1 site in South Korea.
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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 rate as assessed by RECIST criteria (time frame: 21days(1cycle)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 2 Dec 2014.