Stomach NeoplasmsPhase 2NCT00375999
Docetaxel and Epirubicin in Advanced Gastric Cancer
A Phase 2 study testing Docetaxel and epirubicin in people with Stomach Neoplasms, run by Yonsei University at 1 site in South Korea.
Trial summary
1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Docetaxel and epirubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2006to Dec 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male and female outpatients ≥ 18 years,
- Eastern Cooperative Oncology Group performance status below 1, with histologically confirmed as gastric adenocarcinoma with inoperable and/or metastatic disease.
- Patients must have at least one target lesion with a minimum lesion size as per the Response Evaluation Criteria in Solid Tumors criteria (at least 1 unidimensional measurable lesion ≥ 20 mm in diameter by conventional CT or MRI scan, or ≥ 10 mm in diameter by spiral CT scan).
- Creatinine clearance ≥ 60ml/min (estimated creatinine clearance must be calculated at baseline for all patients.)
- Adequate major organ function : - Hematopoietic function: white blood cell >4,000/mm3 or absolute neutrophil count > 2,000/mm3, Platelet count ≥ 100,000/mm3,- Hepatic function: Bilirubin < 1.5 X upper normal limit, aspartate aminotransferase/alanine aminotransferase levels <2.5 X upper normal limit, alkaline phosphatase < 5 x upper normal limit (except in case of bone metastasis without any liver disease) - Renal function: Creatinine <1 x upper normal limit or creatinine clearance ≥ 60ml/min.
Who cannot join
- Patients must not have previously received systemic treatment (cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease.
- Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
- The following laboratory values: - neutrophils ≤1.5 X 109 /L, platelet count<100 X 109 /L- serum bilirubin ≥ 1.5 X upper normal limit, aspartate aminotransferase
- , alanine aminotransferase > 2.5 X upper normal limit or > 5 X upper normal limit in the case of liver metastases- Alkaline phosphatase > 2.5 X upper normal limit or 5 X upper normal limit in the case of liver metastases or > 10 X upper normal limit in the case of bone disease.
- Prior therapy with Taxotere or Epirubicin is excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer.
1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response 3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1 as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks. 4.Primary endpoints:
- Efficacy:overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria, time to response, duration of response, and time to treatment failure.
- Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0).
- Conditions
- Stomach Neoplasms
- Being tested
- Docetaxel and epirubicin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel and epirubicinDrug
Also called taxotere, pharmorubicin
| Study group | Role | What they receive |
|---|---|---|
| docetaxel and epirubicin | Experimental | salvage docetaxel and epirubicin Receives: Drug: Docetaxel and epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Yong Cho, Yonsei University
- Investigators
- Jae Yong Cho, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375999
- Sponsor's protocol ID
- 2004-232
- Status last verified
- Jan 2014
- First submitted
- 13 Sep 2006
- Last updated
- 3 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lim JY, Cho JY, Paik YH, Lee DK, Lee SI, Park HJ, Lee SJ, Lee KS, Yoon DS, Choi SH. Salvage chemotherapy with docetaxel and epirubicin for advanced/metastatic gastric cancer. Oncology. 2007;73(1-2):2-8. doi: 10.1159/000120027. Epub 2008 Mar 10.
PubMed 18332648
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer.
- ClinicalTrials.gov ID
- NCT00375999
- Acronym / sponsor ID
- 2004-232
- Conditions
- Stomach Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 14 Sep 2006 (estimated)
- Results
- Posted 3 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response 3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1 as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks. 4.Primary endpoints:
- Efficacy:overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria, time to response, duration of response, and time to treatment failure.
- Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| docetaxel and epirubicin | Experimental | Drug: Docetaxel and epirubicinsalvage docetaxel and epirubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female outpatients ≥ 18 years,
- Eastern Cooperative Oncology Group performance status below 1, with histologically confirmed as gastric adenocarcinoma with inoperable and/or metastatic disease.
- Patients must have at least one target lesion with a minimum lesion size as per the Response Evaluation Criteria in Solid Tumors criteria (at least 1 unidimensional measurable lesion ≥ 20 mm in diameter by conventional CT or MRI scan, or ≥ 10 mm in diameter by spiral CT scan).
- Creatinine clearance ≥ 60ml/min (estimated creatinine clearance must be calculated at baseline for all patients.)
- Adequate major organ function : - Hematopoietic function: white blood cell >4,000/mm3 or absolute neutrophil count > 2,000/mm3, Platelet count ≥ 100,000/mm3,- Hepatic function: Bilirubin < 1.5 X upper normal limit, aspartate aminotransferase/alanine aminotransferase levels <2.5 X upper normal limit, alkaline phosphatase < 5 x upper normal limit (except in case of bone metastasis without any liver disease) - Renal function: Creatinine <1 x upper normal limit or creatinine clearance ≥ 60ml/min.
Key exclusion criteria (5 listed)
- Patients must not have previously received systemic treatment (cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease.
- Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
- The following laboratory values: - neutrophils ≤1.5 X 109 /L, platelet count<100 X 109 /L- serum bilirubin ≥ 1.5 X upper normal limit, aspartate aminotransferase
- , alanine aminotransferase > 2.5 X upper normal limit or > 5 X upper normal limit in the case of liver metastases- Alkaline phosphatase > 2.5 X upper normal limit or 5 X upper normal limit in the case of liver metastases or > 10 X upper normal limit in the case of bone disease.
- Prior therapy with Taxotere or Epirubicin is excluded.
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 |
|---|---|---|
| Docetaxel and epirubicinAlso: taxotere, pharmorubicin | Drug | docetaxel and epirubicin |
Primary outcome
Overall Survival
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18332648Lim JY, Cho JY, Paik YH, Lee DK, Lee SI, Park HJ, Lee SJ, Lee KS, Yoon DS, Choi SH. Salvage chemotherapy with docetaxel and epirubicin for advanced/metastatic gastric cancer. Oncology. 2007;73(1-2):2-8. doi: 10.1159/000120027. Epub 2008 Mar 10.
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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.
Jae Yong Cho 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 Docetaxel and epirubicin in people with Stomach Neoplasms, 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?
The sponsor lists 5 inclusion and 5 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 3 Mar 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?
Yes. Results are posted in the registry (first posted 3 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (time frame: One year). 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 NCT00375999, 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 3 Mar 2014.