Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448760
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2007-03-15
Brief Title:
Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
A Nonrandomized Phase II Study Feasibility and Outcome of Neo Adjuvant Chemotherapy With Oxaliplatin Fluorodeoxyuridine FUdR Taxotere and Leucovorin in the Treatment of Previously Untreated Advanced Esophago-Gastric Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as oxaliplatin floxuridine docetaxel and leucovorin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with previously untreated stage II or stage III esophageal cancer that can be removed by surgery
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with previously untreated stage II or stage III esophageal cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine whether neoadjuvant chemotherapy comprising oxaliplatin floxuridine docetaxel and leucovorin calcium improves the rate of pathologic complete response in patients with previously untreated resectable stage II or III adenocarcinoma of the esophagus
Secondary
Determine the progression-free and overall survival of patients treated with this regimen
Determine the clinical response rates complete response and partial response in patients treated with this regimen
Evaluate thymidylate synthase TS mRNA gene expression TS activity and TS and mRNA sequence to determine the altered spots as related to drug resistance in these patients
Evaluate the potential for genome-wide gene expression profiling to predict response to therapy recurrence progression-free survival overall survival and drug sensitivity and resistance in these patients
Define the role of 5 untranslated region 5-UTR on translation and drug resistance in these patients
Evaluate by bone marrow aspirate analysis and flow cytometry the initial presence of cancer cells in the marrow and clearance of these cells after treatment with this regimen
Evaluate the safety of this regimen in these patients
Assess quality of life of patients during and after treatment with this regimen
OUTLINE This is a nonrandomized open-label study
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and docetaxel IV over 30 minutes floxuridine IV over 24 hours and leucovorin calcium IV over 24 hours on days 1 8 and 15 Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
Patients undergo surgery after completion of chemotherapy Patients who achieve pathologic complete response pCR receive no further chemotherapy Patients who have not achieved a pCR receive 2 courses of adjuvant chemotherapy same regimen as the neoadjuvant chemotherapy beginning 3 weeks after surgery
Patients undergo blood and tissue collection periodically for correlative studies Samples are analyzed for thymidylate synthase TS mRNA gene expression TS activity and TS and mRNA sequence by bone marrow aspirate flow cytometry and quantitative reverse transcriptase-polymerase chain reaction
Quality of life will be assessed at baseline after neoadjuvant chemotherapy after adjuvant therapy and at the first 3-month follow-up visit
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 34 patients will be accrued for this study
Primary
Determine whether neoadjuvant chemotherapy comprising oxaliplatin floxuridine docetaxel and leucovorin calcium improves the rate of pathologic complete response in patients with previously untreated resectable stage II or III adenocarcinoma of the esophagus
Secondary
Determine the progression-free and overall survival of patients treated with this regimen
Determine the clinical response rates complete response and partial response in patients treated with this regimen
Evaluate thymidylate synthase TS mRNA gene expression TS activity and TS and mRNA sequence to determine the altered spots as related to drug resistance in these patients
Evaluate the potential for genome-wide gene expression profiling to predict response to therapy recurrence progression-free survival overall survival and drug sensitivity and resistance in these patients
Define the role of 5 untranslated region 5-UTR on translation and drug resistance in these patients
Evaluate by bone marrow aspirate analysis and flow cytometry the initial presence of cancer cells in the marrow and clearance of these cells after treatment with this regimen
Evaluate the safety of this regimen in these patients
Assess quality of life of patients during and after treatment with this regimen
OUTLINE This is a nonrandomized open-label study
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and docetaxel IV over 30 minutes floxuridine IV over 24 hours and leucovorin calcium IV over 24 hours on days 1 8 and 15 Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
Patients undergo surgery after completion of chemotherapy Patients who achieve pathologic complete response pCR receive no further chemotherapy Patients who have not achieved a pCR receive 2 courses of adjuvant chemotherapy same regimen as the neoadjuvant chemotherapy beginning 3 weeks after surgery
Patients undergo blood and tissue collection periodically for correlative studies Samples are analyzed for thymidylate synthase TS mRNA gene expression TS activity and TS and mRNA sequence by bone marrow aspirate flow cytometry and quantitative reverse transcriptase-polymerase chain reaction
Quality of life will be assessed at baseline after neoadjuvant chemotherapy after adjuvant therapy and at the first 3-month follow-up visit
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 34 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WIRB-20051464 | OTHER | Western Institutional Review Board | None |
| SCCC-2003151 | OTHER | None | None |