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Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery
This study has been suspended.
Sponsored by: Sylvester Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00448760
  Purpose

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 Intervention Phase
Esophageal Cancer
Drug: docetaxel
Drug: floxuridine
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: flow cytometry
Procedure: gene expression profiling
Procedure: neoadjuvant therapy
Procedure: reverse transcriptase-polymerase chain reaction
Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders
Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Docetaxel Floxuridine Oxaliplatin Calcium gluconate Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, 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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pathologic complete response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response rates (complete response, partial response, overall response) [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: October 2004
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of adenocarcinoma of the esophagus meeting the following criteria:

    • Stage II or III disease
    • Resectable disease
    • Previously untreated disease
  • No stage I (mucosal only) or stage IV (metastatic) disease

PATIENT CHARACTERISTICS:

  • WBC > 3,000/mm^3
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin < 2 times normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must have central venous access
  • No other malignancy within the past 5 years
  • No concurrent medical or psychiatric problem that would preclude study treatment
  • No contraindications to paclitaxel

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy to the esophagus
  • No oral cryotherapy (e.g., ice chips) on day 1 of each course
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448760

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
Sylvester Cancer Center
Investigators
Study Chair: Bach Ardalan, MD Sylvester Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center - Miami ( Bach Ardalan )
Study ID Numbers: CDR0000534102, SCCC-2003151, SCCC-20040006, SANOFI-SCCC-2003151, SCCC-PR200406160033, SCCC-20051464
Study First Received: March 15, 2007
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00448760  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II esophageal cancer
stage III esophageal cancer
adenocarcinoma of the esophagus

Study placed in the following topic categories:
Digestive System Neoplasms
Esophageal disorder
Floxuridine
Gastrointestinal Diseases
Esophageal Neoplasms
Leucovorin
Stomach cancer
Carcinoma
Naphazoline
Docetaxel
Calcium, Dietary
Oxymetazoline
Oxaliplatin
Digestive System Diseases
Guaifenesin
Phenylephrine
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Phenylpropanolamine
Esophageal Diseases
Adenocarcinoma
Esophageal neoplasm

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 14, 2009