Lung CancerPhase 2NCT00453167
Weekly Paclitaxel Plus Gemcitabine as Second-line in Small Cell Lung Cancer
A Phase 2 study testing Paclitaxel and Gemcitabine in people with Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
As a single agent, paclitaxel has a response rate of 33% and 25-29% in SCLC patients with sensitive relapse and with resistant relapse, respectively. As a single agent, gemcitabine also has a response rate 16% and 6-13% in SCLC patients with sensitive relapse and with resistant relapse, respectively. 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?
- Paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2005to Mar 2010
- 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
Who may be able to join
- Histologically or cytologically confirmed SCLC
- Clinically diagnosed metastatic or recurrent SCLC according to Sixth Edition of the AJCC Cancer Staging Manual
- At least 18 years old
- ECOG performance status 0-2
- Disease status must be that of measurable disease defined as RECIST:Lesions that can be accurately measured in at least one dimension > 10 mm with chest x-ray, spiral CT scan or physical examination
- Progression during or after prior first line chemotherapy or chemoradiotherapy.
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- Before study entry, a minimum of 21 days must have elapsed since any prior chemotherapy or radiation
- No prior radiotherapy to measurable lesion(s) but previous surgery and/or chest radiotherapy for the primary lesion is allowed
- Adequate major organ function including the following:Hematologic function: WBC ≥ 3,500/mm3 or absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥ 100,000/mm3Hepatic function: bilirubin ≤ 1.5 x UNL , AST/ALT levels ≤ 2.5 x UNLRenal function: serum creatinine ≤ 1.5mg/dL
- Patients should sign an informed consent
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study registration.
Who cannot join
- MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
- Other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
- Pregnant or nursing women
- Psychiatric disorder that would preclude compliance.
- Major surgery other than biopsy within the past two weeks.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 411-769
About this study
Official title: A Phase II Study of Weekly Paclitaxel and Gemcitabine as Second-line Therapy in Patients With Metastatic or Recurrence Small Cell Lung Cancer
As a single agent, paclitaxel has a response rate of 33% and 25-29% in SCLC patients with sensitive relapse and with resistant relapse, respectively. As a single agent, gemcitabine also has a response rate 16% and 6-13% in SCLC patients with sensitive relapse and with resistant relapse, respectively. Because of single-agent activity, different mechanism of action, non-overlapping toxicities, and beneficial pharmacologic interaction, paclitaxel and gemcitabine combinations are attractive for testing in clinical trials.
Read the detailed description
The treatment consists of paclitaxel 80 mg/m2 and gemcitabine 1,000 mg/m2 given intravenously on days 1 and 8 of a 21-day cycle.
Patients receive treatment every 3 weeks till disease progression
- Conditions
- Lung Cancer
- Being tested
- Paclitaxel, Gemcitabine
- Keywords
- Small cell lung cancer, second-line therapy
- 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.
PaclitaxelDrug
Paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
GemcitabineDrug
Gemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | Not described Receives: Drug: Paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the response rate of paclitaxel plus gemcitabine
Measured: the ratio between the number of responders and number of patients assessable for tumor response
Secondary outcomes (4)
To access the toxicity
Measured: the first day of the treatment to 30 days after the last dose of study drug
To estimate the time to progression
Measured: the first day of treatment to the date that disease progression is reported
To examine the association between genotypes of paclitaxel biotransformation and the pharmacokinetics /
Measured: before the first treatment date, each response evaluation until disease progression
To estimate the overall survival
Measured: the first day of treatment to death date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startDec 2005
- Primary completionDec 2009
- Study completionMar 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Heung Tae Kim, M.D., Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453167
- Sponsor's protocol ID
- NCCCTS-05-155
- Status last verified
- Jul 2010
- First submitted
- 27 Mar 2007
- Last updated
- 12 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Weekly Paclitaxel and Gemcitabine as Second-line Therapy in Patients With Metastatic or Recurrence Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00453167
- Acronym / sponsor ID
- NCCCTS-05-155
- Conditions
- Lung Cancer
- Keywords
- Small cell lung cancer, second-line therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Dec 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Mar 2007 (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.
As a single agent, paclitaxel has a response rate of 33% and 25-29% in SCLC patients with sensitive relapse and with resistant relapse, respectively. As a single agent, gemcitabine also has a response rate 16% and 6-13% in SCLC patients with sensitive relapse and with resistant relapse, respectively. Because of single-agent activity, different mechanism of action, non-overlapping toxicities, and beneficial pharmacologic interaction, paclitaxel and gemcitabine combinations are attractive for testing in clinical trials.
Detailed description
The treatment consists of paclitaxel 80 mg/m2 and gemcitabine 1,000 mg/m2 given intravenously on days 1 and 8 of a 21-day cycle.
Patients receive treatment every 3 weeks till disease progression
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Drug: Paclitaxel, Drug: Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed SCLC
- Clinically diagnosed metastatic or recurrent SCLC according to Sixth Edition of the AJCC Cancer Staging Manual
- At least 18 years old
- ECOG performance status 0-2
- Disease status must be that of measurable disease defined as RECIST:Lesions that can be accurately measured in at least one dimension > 10 mm with chest x-ray, spiral CT scan or physical examination
Key exclusion criteria (6 listed)
- MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
- Other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
- Pregnant or nursing women
- Psychiatric disorder that would preclude compliance.
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 |
|---|---|---|
| PaclitaxelPaclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression | Drug | study arm |
| GemcitabineGemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression | Drug | study arm |
Primary outcome
To evaluate the response rate of paclitaxel plus gemcitabine
Time frame: the ratio between the number of responders and number of patients assessable for tumor response
4 secondary outcomes
To access the toxicity
Time frame: the first day of the treatment to 30 days after the last dose of study drug
To estimate the time to progression
Time frame: the first day of treatment to the date that disease progression is reported
To examine the association between genotypes of paclitaxel biotransformation and the pharmacokinetics /
Time frame: before the first treatment date, each response evaluation until disease progression
To estimate the overall survival
Time frame: the first day of treatment to death date
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 12 Jul 2010.
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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.
Heung Tae Kim, M.D. principal investigator
National Cancer Center, Korea
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 Paclitaxel and Gemcitabine in people with Lung Cancer, run by National Cancer Center, Korea 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?
The sponsor lists 11 inclusion and 6 exclusion criteria. 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 12 Jul 2010. 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?
To evaluate the response rate of paclitaxel plus gemcitabine (time frame: the ratio between the number of responders and number of patients assessable for tumor response). 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 12 Jul 2010.