Gastric CancerPhase 2P-HDFL-DINCT00166881
Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin
A Phase 2 study testing Docetaxel-Irinotecan in people with Gastric Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (~ 60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with non-resectable gastric cancer. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Docetaxel-Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2000to Jun 2011
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed gastric adenocarcinoma
- Measurable or evaluable disease
- No previous C/T
- Age 16 ~ 75 years
- Karnofsky Performance Status of 60%
- 4 weeks after R/T
- Adjuvant C/T: the last dosing of C/T 6 months before enrollment
- WBC >= 4,000, platelets >= 100K, Creatinine <= 1.5mg/dl and proteinuria <1+, normal serum bil, transaminase <= 3.5x ULN, TG > 70mg/dl
Who cannot join
- CNS metastasis
- Patients receive concomitant anti-cancer C/T or R/T
- Patients who are pregnant and with an expected life expectancy less than 3 months
- Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Oncology, National Taiwan University Hospital
Taipei, 100
About this study
Official title: Phase II Trial of Consolidation or Salvage Chemotherapy by Using Weekly Docetaxel/Irinotecan After Cisplatin Plus Weekly 24-Hour Infusion of High-dose 5-Fluorouracil/Leucovorin for Non-resectable Gastric Cancers
In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (~ 60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with non-resectable gastric cancer. For those patients who have achieved complete response (CR) or partial response (PR), DI will be used to "consolidate" the remission. For those patients who fail to achieve remission by P-HDFL, DI will be used as salvage chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in this prospective study.
Read the detailed description
- To evaluate if weekly Docetaxel-Irinotecan,a potentially non-cross-resistant regimen,can prolong the overall survival (OS) or the duration of remission in those patients who have achieved CR or PR by P-HDFL regimen
- To evaluate the efficacy of weekly Docetaxel-Irinotecan combination as salvage regimen for those patients who have either failed to achieve remission or have recurred from P-HDFL chemotherapy
- To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients
- To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers
- Conditions
- Gastric Cancer
- Being tested
- Docetaxel-Irinotecan
- Keywords
- Combination, Chemotherapy, Inoperable Gastric Cancer
- 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-IrinotecanDrug
Also called Docetaxel (taxotere), Irinotecan (campto, CPT-11)
Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| A, 2, III | Experimental | Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL Receives: Drug: Docetaxel-Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: Five years
Secondary outcomes (1)
Objective response rates (CR, PR)
Measured: Confirmed objective response after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJun 2000
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Far Eastern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Ann-Lii Cheng, M.D.,Ph.D., Study chair, Department of Oncology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166881
- Sponsor's protocol ID
- 57M9
- Acronym
- P-HDFL-DI
- Status last verified
- Nov 2012
- First submitted
- 12 Sep 2005
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Consolidation or Salvage Chemotherapy by Using Weekly Docetaxel/Irinotecan After Cisplatin Plus Weekly 24-Hour Infusion of High-dose 5-Fluorouracil/Leucovorin for Non-resectable Gastric Cancers
- ClinicalTrials.gov ID
- NCT00166881
- Acronym / sponsor ID
- P-HDFL-DI / 57M9
- Conditions
- Gastric Cancer
- Keywords
- Combination, Chemotherapy, Inoperable Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Far Eastern Memorial Hospital
- Study start
- Jun 2000
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Sep 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.
In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (~ 60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with non-resectable gastric cancer. For those patients who have achieved complete response (CR) or partial response (PR), DI will be used to "consolidate" the remission. For those patients who fail to achieve remission by P-HDFL, DI will be used as salvage chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in this prospective study.
Detailed description
- To evaluate if weekly Docetaxel-Irinotecan,a potentially non-cross-resistant regimen,can prolong the overall survival (OS) or the duration of remission in those patients who have achieved CR or PR by P-HDFL regimen
- To evaluate the efficacy of weekly Docetaxel-Irinotecan combination as salvage regimen for those patients who have either failed to achieve remission or have recurred from P-HDFL chemotherapy
- To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients
- To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A, 2, III | Experimental | Drug: Docetaxel-IrinotecanWeekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed gastric adenocarcinoma
- Measurable or evaluable disease
- No previous C/T
- Age 16 ~ 75 years
- Karnofsky Performance Status of 60%
Key exclusion criteria (4 listed)
- CNS metastasis
- Patients receive concomitant anti-cancer C/T or R/T
- Patients who are pregnant and with an expected life expectancy less than 3 months
- Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis
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-IrinotecanAlso: Docetaxel (taxotere), Irinotecan (campto, CPT-11)Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks | Drug | A, 2, III |
Primary outcome
Overall survival (OS)
Time frame: Five years
1 secondary outcome
Objective response rates (CR, PR)
Time frame: Confirmed objective response after 4 weeks
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 8 Jul 2013.
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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.
Ann-Lii Cheng, M.D.,Ph.D. study chair
Department of Oncology, National Taiwan University Hospital
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-Irinotecan in people with Gastric Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 inclusion and 4 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 8 Jul 2013. 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 Taiwan. 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?
Overall survival (OS) (time frame: Five years). 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 8 Jul 2013.