RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with panitumumab and radiation therapy 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 giving panitumumab together with docetaxel, cisplatin, radiation therapy, and surgery works in treating patients with newly diagnosed, locally advanced esophageal cancer or cancer of the gastroesophageal junction.
OBJECTIVES: Primary * To determine the pathologic complete response rate in patients with newly diagnosed, locally advanced adenocarcinoma of the distal esophagus or gastroesophageal junction treated with neoadjuvant panitumumab and combination chemoradiotherapy followed by surgery. Secondary * To determine the near-complete pathologic response rate in the primary tumor (≤ 10% residual viable cancer). * To determine the overall survival and disease-free survival rates of these patients. * To determine the safety profile of this regimen. OUTLINE: Patients receive panitumumab IV over 1 hour, docetaxel IV over 1 hour, and cisplatin IV over 1-2 hours on day 1 in weeks 1, 3, 5, 7, and 9. Patients also undergo radiotherapy once daily 5 days a week beginning in week 5 and continuing for 5.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 6-9 weeks after completion of chemoradiotherapy, patients with no evidence of metastatic disease undergo esophagectomy. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year OR every 6 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
Simmons Cooper Cancer Institute
Springfield, Illinois, United States
Central Baptist Hospital
Lexington, Kentucky, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
...and 11 more locations
Number of Participants With Pathologic Complete Response Following Surgery
Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.
Time frame: Post surgery
Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)
Time frame: Post surgery
Percentage of Participants With 3-year Overall Survival
Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).
Time frame: 3 years
Percentage of Participants With 2-year Disease-free Survival
Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.
Time frame: 2 years
Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution
Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.
Time frame: Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.