Esophageal CancerPhase 1/2NCT00209716
Phase I/II Study of Taxotere,CDDP and 5-FU(TPF) in Pre-treated Pts With Metastatic Esophageal Cancer.
A Phase 1/2 study testing Taxotere, 5-Fluorouracil and Briplatin in people with Esophageal Cancer, run by Hokkaido Gastrointestinal Cancer Study Group at 1 site in Japan.
Trial summary
A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (TPF) in Pre-treated patients with metastatic esophageal cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Taxotere, 5-Fluorouracil and Briplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2003to Nov 2009
- Phase
- Phase 1/2
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic or recurrent esophageal tumors with previous treatment for advanced disease.(Except for small cell carcinoma)
- At least one measurable lesion according to the RECIST criteria. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques(Except for Phase I setting).
- Patients aged between 20 and 75 years, inclusive, at the time of acquisition of informed consent
- Patients with performance status(ECOG) 0 to 2
- Abnormal hematologic values (WBC ≥ 3.5 x 109/L, Hemoglobin ≥ 9.5g/dl, platelet count ≥ 100 x 109/L)
- Creatinine clearance ≥ 60 ml/min, Serum cleatinine ≤ 1.5mg/dl
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- Serum bilirubin ≤ 1.5mg/dl. ALT, AST ≤ 2.5 x upper normal limit (or ≤ 3 x upper normal limit in the case of liver metastases)
- Patients who have received 1cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given > 4 weeks prior to the beginning of study therapy
- Life expectancy ≥ 3 months
- Patients who have given written informed consent to participate in this study
Who cannot join
- Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer) (Except for Phase I setting)
- Serious, uncontrolled, concurrent infection(s) or illness(es)
- Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
- Patients with brain metastasis
- Patients receiving continuous administration of steroids
- Patients who have experienced serious drug allergy in the past
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- Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment
- Patients who are pregnant and lactating or hope to become pregnant during the study period
- Patients with prior Taxan treatment (Paclitaxel, Docetaxel)
- Patients with edema ≥ grade 2
- Others, patients judged by the investigator or subinvestigator to be inappropriate as subject
Trial locations and contacts
1 site in 1 country.
Japan1 site
・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
Sapporo, Hokkaido, 060-8638
About this study
Official title: Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as Chemotherapy in Pre-treated Patients With Metastatic Esophageal Cancer.
A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (TPF) in Pre-treated patients with metastatic esophageal cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.
Read the detailed description
Patients with pre-treated measurable metastatic esophageal cancer were included in this trial. Patients received this combination chemotherapy repeated every 28 days until progression disease. Starting dose (dose level 1) were docetaxel 30 mg/m2 on day 1, fixed dose intravenously cisplatin (15 mg/m2/day) and continuous infusion 5-FU (800 mg/m2/day) on day 1-4. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia lasting for more than 4days, Grade 4 anemia and thrombocytopenia, Grade 3 neutropenia accompanied fever (>38℃) , and Grade 3 non-hematological toxicity (except for nausea, appetite loss , general fatigue). Maximal Tolerated Dose (MTD) is determined when the incidence of critical toxicity exceeds 50% at a certain dose level. Response rate will be calculated according to RECIST criteria.
- Conditions
- Esophageal Cancer
- Being tested
- Taxotere, 5-Fluorouracil, Briplatin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxotereDrug
Also called Docetaxel
30 mg/m2, IV (in the vein) on day 1 of each 28 day cycle.
5-FluorouracilDrug
Also called fluorouracil
800 mg/m2, CIV (CIV.in the vein) on day 1~5 of each 28 day cycle.
BriplatinDrug
Also called Cisplatin
15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Taxotere; Drug: 5-Fluorouracil; Drug: Briplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting.
Measured: 1 year
Secondary outcomes (2)
Determine the clinical response rate of patients in Phase I setting.
Measured: 1-year
Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting.
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hokkaido Gastrointestinal Cancer Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Hokkaido University Hospital
- Investigators
- Masahiro Asaka, MD, PhD, Study chair, Hokkaido Gastrointestinal Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209716
- Sponsor's protocol ID
- HGCSG0305-2
- Other IDs
- TPF-2
- Status last verified
- May 2010
- First submitted
- 13 Sep 2005
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as Chemotherapy in Pre-treated Patients With Metastatic Esophageal Cancer.
- ClinicalTrials.gov ID
- NCT00209716
- Acronym / sponsor ID
- HGCSG0305-2
- Conditions
- Esophageal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hokkaido Gastrointestinal Cancer Study GroupUniversity, hospital or other
- Collaborators
- Hokkaido University Hospital
- Study start
- Dec 2003
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 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.
A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (TPF) in Pre-treated patients with metastatic esophageal cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.
Detailed description
Patients with pre-treated measurable metastatic esophageal cancer were included in this trial. Patients received this combination chemotherapy repeated every 28 days until progression disease. Starting dose (dose level 1) were docetaxel 30 mg/m2 on day 1, fixed dose intravenously cisplatin (15 mg/m2/day) and continuous infusion 5-FU (800 mg/m2/day) on day 1-4. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia lasting for more than 4days, Grade 4 anemia and thrombocytopenia, Grade 3 neutropenia accompanied fever (>38℃) , and Grade 3 non-hematological toxicity (except for nausea, appetite loss , general fatigue). Maximal Tolerated Dose (MTD) is determined when the incidence of critical toxicity exceeds 50% at a certain dose level. Response rate will be calculated according to RECIST criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Taxotere, Drug: 5-Fluorouracil, Drug: Briplatin |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed metastatic or recurrent esophageal tumors with previous treatment for advanced disease.(Except for small cell carcinoma)
- At least one measurable lesion according to the RECIST criteria. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques(Except for Phase I setting).
- Patients aged between 20 and 75 years, inclusive, at the time of acquisition of informed consent
- Patients with performance status(ECOG) 0 to 2
- Abnormal hematologic values (WBC ≥ 3.5 x 109/L, Hemoglobin ≥ 9.5g/dl, platelet count ≥ 100 x 109/L)
Key exclusion criteria (11 listed)
- Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer) (Except for Phase I setting)
- Serious, uncontrolled, concurrent infection(s) or illness(es)
- Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
- Patients with brain metastasis
- Patients receiving continuous administration of steroids
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 |
|---|---|---|
| TaxotereAlso: Docetaxel30 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. | Drug | 1 |
| 5-FluorouracilAlso: fluorouracil800 mg/m2, CIV (CIV.in the vein) on day 1~5 of each 28 day cycle. | Drug | 1 |
| BriplatinAlso: Cisplatin15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle. | Drug | 1 |
Primary outcome
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting.
Time frame: 1 year
2 secondary outcomes
Determine the clinical response rate of patients in Phase I setting.
Time frame: 1-year
Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting.
Time frame: 2-years
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 26 May 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.
Masahiro Asaka, MD, PhD study chair
Hokkaido Gastrointestinal Cancer Study Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Taxotere, 5-Fluorouracil and Briplatin in people with Esophageal Cancer, run by Hokkaido Gastrointestinal Cancer Study Group at 1 site in Japan.
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 10 inclusion and 11 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 26 May 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 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 combined 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.
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?
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting. (time frame: 1 year). 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 26 May 2010.