Esophageal NeoplasmPhase 2NCT00037089
A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients With Metastatic Esophageal Cancer
A Phase 2 study testing UFT (Tegafur/Uracil) in people with Esophageal Neoplasm, run by Edelman, Martin, M.D. at 1 site in United States.
Trial summary
This study is for patients with esophageal cancer that has spread to other areas. The purpose of this study is to: 1. Determine how well a combination of taxol, UFT, and leucovorin work in these patients, 2. Determine the survival of patients with metastatic esophageal carcinoma treated with this combination of drugs. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Esophageal Neoplasm
- What is being tested?
- UFT (Tegafur/Uracil)
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic proof of esophageal cancer
- No more than one prior non-taxane chemotherapy regimen for either treatment of localized disease or metastatic disease AND they may not have received a regimen containing low dose continuous infusion of 5-FU (i.e. >5 days of infusion/cycle), capecitabine or UFT
- No prior therapy with UFT+/-leucovorin, a taxane, capecitabine, low dose continuous infusion of 5-FU or ethynyl uracil.
- Radiographic or physical examination documentation of metastatic disease
- No major surgery within the 2 weeks preceding the start of treatment and fully recovered from any complications of surgery
- No radiation within 2 weeks of beginning chemotherapy.
Show all 11Show fewer
- No chemotherapy within 4 weeks of beginning treatment.
- Patients must wait at least 6 weeks after receiving BCNU or Mitomycin-C.
- Minimum life expectancy of 3 months
- Informed consent given
- Laboratory values within limits set by study.
Who cannot join
- More than one prior chemotherapy regimen for metastatic disease
- Current serious medical or psychiatric illness that would prevent informed consent or intensive treatment
- >grade 1 peripheral sensory or motor neuropathy
- Pregnant
- Patient is taking the drug Sorivudine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Cancer Center
Baltimore, Maryland, 21201
About this study
This study is for patients with esophageal cancer that has spread to other areas. The purpose of this study is to:
- Determine how well a combination of taxol, UFT, and leucovorin work in these patients,
- Determine the survival of patients with metastatic esophageal carcinoma treated with this combination of drugs.
- Identify the side effects of this drug combination.
- Conditions
- Esophageal Neoplasm
- Being tested
- UFT (Tegafur/Uracil)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UFT (Tegafur/Uracil)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmStudies 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
Sponsor and investigators
- Lead sponsor
- Edelman, Martin, M.D.
- Collaborators
- Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037089
- Sponsor's protocol ID
- BMS-200604
- Other IDs
- UMCC 0110g
- Status last verified
- Jan 2005
- First submitted
- 14 May 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients With Metastatic Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00037089
- Acronym / sponsor ID
- BMS-200604
- Conditions
- Esophageal Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Edelman, Martin, M.D.
- Collaborators
- Bristol-Myers Squibb
- First posted
- 15 May 2002 (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 study is for patients with esophageal cancer that has spread to other areas. The purpose of this study is to:
- Determine how well a combination of taxol, UFT, and leucovorin work in these patients,
- Determine the survival of patients with metastatic esophageal carcinoma treated with this combination of drugs.
- Identify the side effects of this drug combination.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologic proof of esophageal cancer
- No more than one prior non-taxane chemotherapy regimen for either treatment of localized disease or metastatic disease AND they may not have received a regimen containing low dose continuous infusion of 5-FU (i.e. >5 days of infusion/cycle), capecitabine or UFT
- No prior therapy with UFT+/-leucovorin, a taxane, capecitabine, low dose continuous infusion of 5-FU or ethynyl uracil.
- Radiographic or physical examination documentation of metastatic disease
- No major surgery within the 2 weeks preceding the start of treatment and fully recovered from any complications of surgery
Key exclusion criteria (5 listed)
- More than one prior chemotherapy regimen for metastatic disease
- Current serious medical or psychiatric illness that would prevent informed consent or intensive treatment
- >grade 1 peripheral sensory or motor neuropathy
- Pregnant
- Patient is taking the drug Sorivudine
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 |
|---|---|---|
| UFT (Tegafur/Uracil) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 UFT (Tegafur/Uracil) in people with Esophageal Neoplasm, run by Edelman, Martin, M.D. at 1 site in United States.
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 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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 United States. 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?
Results are not available in the source record.
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.
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 24 Jun 2005.