Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00448760|
Recruitment Status : Completed
First Posted : March 19, 2007
Results First Posted : February 18, 2013
Last Update Posted : February 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: Docetaxel Drug: Floxuridine Drug: Leucovorin Drug: Oxaliplatin Genetic: Microarray analysis Genetic: reverse transcriptase-polymerase chain reaction Procedure: Conventional surgery||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
|Experimental: Neoadjuvant + Adjuvant Chemotherapy||
Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Other Name: TaxotereDrug: Floxuridine
Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Other Name: FUdRDrug: Leucovorin
Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cyclesDrug: Oxaliplatin
Intravenously, 85 mg/m2, over 2 hours, 2 cyclesGenetic: Microarray analysis
Analysis of tumor for pathologic response to protocol therapyGenetic: reverse transcriptase-polymerase chain reaction
Analysis of tumor for pathologic response to protocol therapyProcedure: Conventional surgery
Surgical removal of tumor for correlative studies
- Pathologic Complete Response [ Time Frame: 8 - 16 weeks ]No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.
- Clinical Response [ Time Frame: 8 - 16 weeks ]
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.
- Median Progression-free Survival (PFS) [ Time Frame: 24 months ]
- Overall Survival [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448760
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Bach Ardalan, MD||University of Miami Sylvester Comprehensive Cancer Center|