Esophageal CancerPhase 1/2NCT00915850
Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
A Phase 1/2 study testing DCF in people with Esophageal Cancer, run by Wakayama Medical University at 1 site in Japan.
Trial summary
This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- DCF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2007to Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan
- ECOG performance status 0-1
- 20 years and older
- Patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor
- Tissue from tumor must be available
- Patients must have measurable disease
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- Patients may have received prior adjuvant chemotherapy; this must have been completed at least 1 month
- Life expectancy > 3 months
- Laboratory values as follows
- 3000/mm3 < WBC < 12000/mm3
- 1500/mm3 < granulocyte count
- 8.0 gm/dl < hemoglobin
- Platelet count > 100000/mm3
- Aspartate transaminase < 150 IU/L
- Alanine transaminase < 150 IU/L
- Creatinine < 1.5 mg/dl
- Able and willing to give valid written informed consent
Who cannot join
- Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception)
- Active or uncontrolled infection
- Prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or immunotherapy within 1 week
- Clinically significant heart disease
- Patients with a history of myocardial infarction within the previous three months
- Patients with uncontrolled diabetes mellitus or hypertension
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- Presence of clinically apparent central nervous system metastases
- Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Decision of unsuitableness by principal investigator or physician-in-charge
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Wakayama Medical University
Wakayama, Wakayama, 641-8510
Makoto Iwahashi, MD, 81-73-441-0613, makato@wakayama-med.ac.jp
About this study
Official title: Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.
This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness of the this regimen is evaluated by RECIST, time to progression and median survival time.
Read the detailed description
<Phase I>
Primary Objective:
To establish the safety of combination chemotherapy comprising docetaxel (escalating doses: 25,30,35,40 mg/m2,day1 and day8), cisplatin (12mg/m2,day1-5), and fluorouracil (600mg/m2,day1-5) (DCF) in unresectable advanced esophageal cancer.
Secondary Objective:
To observe the efficacy of this regimen in these patients.
<Phase II>
Primary Objective:
To assess the response rate of combination chemotherapy comprising docetaxel (recommended dose determined in phase I study,day1 and day8), cisplatin (12 mg/m2, day1-5), and fluorouracil (600 mg/m2, day1-5) (DCF) in unresectable advanced esophageal cancer.
Secondary Objectives:
To determine the adverse reactions of this regimen in these patients. To determine TTP(Time to progression) of patients treated with this regimen. To determine MST(Median survival time) of patients treated with this regimen.
- Conditions
- Esophageal Cancer
- Being tested
- DCF
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCFDrug
Also called docetaxel+Cisplatin+5-FU
docetaxel, Cisplatin and 5-FU
| Study group | Role | What they receive |
|---|---|---|
| Anticancer drug | Experimental | docetaxel, cisplatin and 5-FU Receives: Drug: DCF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)
Measured: 1 month
Secondary outcomes (5)
To determine the recommended phase II dose of docetaxel (Phase I)
Measured: 1 month
To determine the clinical effectiveness in the patients with measurable disease (Phase I)
Measured: 1 month
To analyze the toxicity (Phase II)
Measured: 1 month
Time to progression (Phase II)
Measured: 5 years
median survival time (Phase II)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startAug 2007
- Primary completionAug 2010 (estimated)
- Study completionAug 2015 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wakayama Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Makoto Iwahashi, M.D., Study director, Second Department of Surgery, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915850
- Sponsor's protocol ID
- WMU-EC01
- Status last verified
- Sep 2010
- First submitted
- 5 Jun 2009
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.
- ClinicalTrials.gov ID
- NCT00915850
- Acronym / sponsor ID
- WMU-EC01
- Conditions
- Esophageal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Wakayama Medical UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 8 Jun 2009 (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.
This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness of the this regimen is evaluated by RECIST, time to progression and median survival time.
Detailed description
<Phase I>
Primary Objective:
To establish the safety of combination chemotherapy comprising docetaxel (escalating doses: 25,30,35,40 mg/m2,day1 and day8), cisplatin (12mg/m2,day1-5), and fluorouracil (600mg/m2,day1-5) (DCF) in unresectable advanced esophageal cancer.
Secondary Objective:
To observe the efficacy of this regimen in these patients.
<Phase II>
Primary Objective:
To assess the response rate of combination chemotherapy comprising docetaxel (recommended dose determined in phase I study,day1 and day8), cisplatin (12 mg/m2, day1-5), and fluorouracil (600 mg/m2, day1-5) (DCF) in unresectable advanced esophageal cancer.
Secondary Objectives:
To determine the adverse reactions of this regimen in these patients. To determine TTP(Time to progression) of patients treated with this regimen. To determine MST(Median survival time) of patients treated with this regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anticancer drug | Experimental | Drug: DCFdocetaxel, cisplatin and 5-FU |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan
- ECOG performance status 0-1
- 20 years and older
- Patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor
- Tissue from tumor must be available
Key exclusion criteria (9 listed)
- Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception)
- Active or uncontrolled infection
- Prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or immunotherapy within 1 week
- Clinically significant heart disease
- Patients with a history of myocardial infarction within the previous three months
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 |
|---|---|---|
| DCFAlso: docetaxel+Cisplatin+5-FUdocetaxel, Cisplatin and 5-FU | Drug | Anticancer drug |
Primary outcome
Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)
Time frame: 1 month
5 secondary outcomes
To determine the recommended phase II dose of docetaxel (Phase I)
Time frame: 1 month
To determine the clinical effectiveness in the patients with measurable disease (Phase I)
Time frame: 1 month
To analyze the toxicity (Phase II)
Time frame: 1 month
Time to progression (Phase II)
Time frame: 5 years
median survival time (Phase II)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 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.
Makoto Iwahashi, M.D. study director
Second Department of Surgery, Wakayama Medical University
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 DCF in people with Esophageal Cancer, run by Wakayama Medical University 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 17 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Makoto Iwahashi, MD (81-73-441-0613, makoto@wakayama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST) (time frame: 1 month). 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 9 Sep 2010.