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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2003151 | Other Identifier | University of Miami Sylvester Comprehensive Cancer Center | |
| WIRB-20051464 | Other Identifier | Western Institutional Review Board |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant + Adjuvant Chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Intravenously, 25 mg/m2, over 30 minutes, 2 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response | No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy. | 8 - 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response | Overall response = Complete response (CR) + Partial Response (PR). Evaluated via endoscopic ultrasounds, PET and CT scans of the chest: Complete Response (CR) applies to participants complete disappearance of all measurable and evaluable disease. No new lesion. No disease related symptoms. No evidence of non-evaluable disease, including tumor markers and other laboratory values. Partial Response (PR) applies to participants with at least 50 percent reduction in the sum of the products of bi-dimensional perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. |
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DISEASE CHARACTERISTICS:
Diagnosis of adenocarcinoma of the esophagus meeting the following criteria:
No stage I (mucosal only) or stage IV (metastatic) disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Bach Ardalan, MD | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21258083 | Result | Solomon N, Mezentsev D, Reis I, Lima M, Rios J, Avisar E, Franceschi D, Livingstone A, Podolsky L, Ardalan B. A phase II study of neoadjuvant and adjuvant chemotherapy with 5-fluorodeoxyuridine, leucovorin, oxaliplatin and docetaxel in the treatment of previously untreated advanced esophageal adenocarcinoma. Jpn J Clin Oncol. 2011 Apr;41(4):469-76. doi: 10.1093/jjco/hyq239. Epub 2011 Jan 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant + Adjuvant Chemotherapy | Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles Conventional surgery : Surgical removal of tumor for correlative studies reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles Microarray analysis : Analysis of tumor for pathologic response to protocol therapy Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Floxuridine | Drug | Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles |
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| Leucovorin | Drug | Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles |
|
| Oxaliplatin | Drug | Intravenously, 85 mg/m2, over 2 hours, 2 cycles |
|
| Microarray analysis | Genetic | Analysis of tumor for pathologic response to protocol therapy |
|
| reverse transcriptase-polymerase chain reaction | Genetic | Analysis of tumor for pathologic response to protocol therapy |
|
| Conventional surgery | Procedure | Surgical removal of tumor for correlative studies |
|
| 8 - 16 weeks |
| Median Progression-free Survival (PFS) | 24 months |
| Overall Survival | 24 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | 5-Fluorodeoxyuridine, Leucovorin, Oxaliplatin and Docetaxel |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathologic Complete Response | No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy. | Posted | Number | 90% Confidence Interval | percentage of participants | 8 - 16 weeks |
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| Secondary | Clinical Response | Overall response = Complete response (CR) + Partial Response (PR). Evaluated via endoscopic ultrasounds, PET and CT scans of the chest: Complete Response (CR) applies to participants complete disappearance of all measurable and evaluable disease. No new lesion. No disease related symptoms. No evidence of non-evaluable disease, including tumor markers and other laboratory values. Partial Response (PR) applies to participants with at least 50 percent reduction in the sum of the products of bi-dimensional perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. | Posted | Number | 90% Confidence Interval | percentage of participants | 8 - 16 weeks |
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| Secondary | Median Progression-free Survival (PFS) | Posted | Median | 95% Confidence Interval | months | 24 months |
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| Secondary | Overall Survival | Posted | Median | 95% Confidence Interval | months | 24 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles Conventional surgery : Surgical removal of tumor for correlative studies reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles Microarray analysis : Analysis of tumor for pathologic response to protocol therapy Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles | 25 | 29 | 0 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3 Neutropenia | Blood and lymphatic system disorders |
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| Grade 4 Neutropenia | Blood and lymphatic system disorders |
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| Grade 3 Febrile Neutropenia | Blood and lymphatic system disorders |
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| Grade 3Thrombocytopenia | Blood and lymphatic system disorders |
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| Grade 3 Fatigue | General disorders |
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| Grade 3 Diarrhea | Gastrointestinal disorders |
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| Grade 3 Deep Venous Thrombosis | General disorders |
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| Grade 3 Nausea | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bach Ardalan MD, Professor | UM/Sylvester Comprehensive Cancer Center | 305-243-4909 | bardalan@med.miami.edu |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D005467 | Floxuridine |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D046228 | Microarray Analysis |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003857 | Deoxyuridine |
| D014529 | Uridine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D046208 | Microchip Analytical Procedures |
| D008919 | Investigative Techniques |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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