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Title   A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma
Study Number   R1010
Trial Type   Oncology-Head and Neck
Condition   Esophageal
Trial Status   Open to Accrual
Principal Investigator   Marshall Levine¬ł MD
Contact¬†Name   Tahisa Hamwright
Phone   (443) 849-3123
Fax   (443) 849-3777
Description  
Estimated Enrollment: 480
Study Start Date: July 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (radiotherapy, chemotherapy, monoclonal antibody)

Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV over 60 minutes and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 36 and trastuzumab IV over 30-90 minutes on days 1, 8, 15, 22, 29, 36, and 57.

Within 5-6 weeks after completion of radiotherapy, all patients undergo surgery.

Beginning 21-56 days after surgery, all patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 13 courses in the absence of disease progression or unacceptable toxicity.

Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Biological: trastuzumab
Given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2
Procedure: therapeutic conventional surgery
Undergo surgery
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm II (radiotherapy, chemotherapy, monoclonal antibody)

Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV over 60 minutes and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 36.

Within 5-6 weeks after completion of radiotherapy, all patients undergo surgery.

Beginning 21-56 days after surgery, all patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 13 courses in the absence of disease progression or unacceptable toxicity.

Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Biological: trastuzumab
Given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2
Procedure: therapeutic conventional surgery
Undergo surgery
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

 

Inclusion/Notes  














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

Criteria


Inclusion Criteria:




  • Pathologically confirmed primary adenocarcinoma of the esophagus meeting the following criteria:




    • Involvement of mid (up to 25 cm), distal, or esophagogastric junction



      • Involvement of the stomach up to 5 cm allowed

      • Patients with tumors at the level of the carina or above must undergo bronchoscopy to exclude fistula




    • Stage T1, N1-2 or T2-3, N0-2 disease by chest, abdominal, or pelvic CT scan or whole-body PET/CT scan



      • No T1,N0 or T4 disease

      • No metastatic disease



    • Regional adenopathy including para-esophageal, gastric, gastrohepatic, and celiac (≤ 2 cm) nodes allowed

    • No cervical esophageal or proximal esophageal (15-24 cm) carcinoma



  • Must have undergone endoscopy with biopsy


  • HER2-overexpressing adenocarcinoma of the esophagus



    • Primary tumor tissue samples must be submitted and centrally assessed within the past 56 days



  • Disease must be encompassed in 1 radiotherapy field

  • Able to undergo curative resection within 56 days after completion of chemoradiation

  • No evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi

  • Zubrod performance status 0-2

  • ANC ≥ 1,500 cells/mm³

  • Platelet count ≥100,000 cells/mm³

  • Hemoglobin (Hb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hb ≥ 8.0 g/dL allowed)

  • Creatinine ≤ 2 times upper limit of normal (ULN)

  • Bilirubin ≤ 1.5 times ULN

  • AST ≤ 3.0 times ULN

  • LVEF normal

  • Negative pregnancy test

  • Not pregnant or nursing

  • Fertile patients must use effective contraception during and for ≥ 60 days after completion of chemotherapy or trastuzumab

  • No prior invasive malignancy except non-melanomatous skin cancer or curatively treated carcinoma in situ of the breast, oral cavity, or cervix with no evidence of disease within the past 2 years

  • No medical contraindications to esophagectomy

  • No prior allergic reaction to the study drugs involved in this protocol or to a monoclonal antibody

  • No history of congestive heart failure


  • No severe or active comorbidity defined as any of the following:



    • Unstable angina within the past 6 months

    • Transmural myocardial infarction within the past 6 months

    • Acute bacterial or fungal infection requiring intravenous antibiotics


    • AIDS or immunocompromised patients



      • HIV testing is not required






  • No prior systemic chemotherapy for esophageal cancer



    • Prior chemotherapy for a different cancer allowed



  • No prior radiotherapy for esophageal cancer or prior chest radiotherapy

  • No prior anthracycline or taxane

  • No prior therapy with any agent targeting the HER2 pathway or HER1 (EGFR) pathway

  • No prior trastuzumab

  • No concurrent intensity-modulated radiotherapy

  • No other concurrent radiotherapy

  • No other concurrent investigational agents

  • No other concurrent cytotoxic agents


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