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Paclitaxel + UFT + Leucovorin for Esophageal Cancer
Phase 2
Waitlist Available
Research Sponsored by Edelman, Martin, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No more than one prior non-taxane chemotherapy regimen for either treatment of localized disease or metastatic disease AND no regimen containing low dose continuous infusion of 5-FU, capecitabine, or UFT
Radiographic or physical examination documentation of metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is for patients with esophageal cancer that has spread to other areas. The purpose is to see if a combination of taxol, UFT, and leucovorin works well and to identify any side effects.
Who is the study for?
This trial is for patients with esophageal cancer that has spread, who have had no more than one prior non-taxane chemo treatment and haven't received certain drugs like UFT or capecitabine. They should be at least 3 months from expected death, not pregnant, without serious illness or neuropathy, and not recently undergone major surgery.Check my eligibility
What is being tested?
The study tests how well a drug combo of Paclitaxel (taxol), UFT, and Leucovorin works in treating metastatic esophageal cancer. It aims to determine the effectiveness in shrinking tumors, improving survival rates, and identifying side effects of this specific regimen.See study design
What are the potential side effects?
Possible side effects may include reactions to the infusion process such as pain or swelling at the injection site, fatigue from treatment-related anemia or general body stress, digestive issues like nausea or diarrhea due to chemotherapy's effect on rapidly dividing cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had only one chemotherapy that wasn't taxane-based and didn't include continuous low-dose 5-FU, capecitabine, or UFT.
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My cancer has spread, as shown by scans or physical exams.
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My cancer diagnosis was confirmed with a tissue sample.
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I haven't had treatments with UFT, taxanes, capecitabine, 5-FU infusion, or ethynyl uracil.
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I haven't had chemotherapy in the last 4 weeks.
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I haven't had major surgery in the last 2 weeks and have recovered from any surgery complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,064 Total Patients Enrolled
22 Trials studying Esophageal Neoplasms
2,415 Patients Enrolled for Esophageal Neoplasms
Edelman, Martin, M.D.Lead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have mild to no nerve damage in my hands or feet.I have waited over 6 weeks since my last BCNU or Mitomycin-C treatment.I have had more than one chemotherapy treatment for my cancer that has spread.I've had only one chemotherapy that wasn't taxane-based and didn't include continuous low-dose 5-FU, capecitabine, or UFT.My cancer has spread, as shown by scans or physical exams.I haven't had radiation in the last 2 weeks.My cancer diagnosis was confirmed with a tissue sample.I haven't had treatments with UFT, taxanes, capecitabine, 5-FU infusion, or ethynyl uracil.I haven't had chemotherapy in the last 4 weeks.I haven't had major surgery in the last 2 weeks and have recovered from any surgery complications.I am currently taking Sorivudine.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research require participants to be a certain age?
"This trial is for adults aged 18 to 79. There are six clinical trials aimed at minors and 288 trials focusing on elderly patients."
Answered by AI
Has this particular medication been cleared by the FDA?
"While there is some data suggesting this intervention is safe, it received a score of 2 because, as a Phase 2 trial, there is no supporting evidence for efficacy."
Answered by AI
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