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A Phase II Study of Neoadjuvant Therapy With Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of the Distal Esophagus

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer

Thank you

Trial Information

A Phase II Study of Neoadjuvant Therapy With Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of the Distal Esophagus



- 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


- 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.

Inclusion Criteria


- Biopsy-proven adenocarcinoma of the distal esophagus or gastroesophageal junction,
meeting all of the following criteria:

- Siewert type I or II disease

- Newly diagnosed disease (nonrecurrent)

- Resectable disease

- Clinical stage T1-3,N1,M0; T3,N0,M0; or T1-3,N0-1,M1a (celiac adenopathy must be ≤ 2
cm by esophageal ultrasound) disease

- No T1 tumors or T2,N0,M0 tumors allowed

- Locally advanced disease

- No definitive radiological evidence of distant metastases


- ECOG/Zubrod performance status 0-1

- WBC ≥ 3,000/mm³

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.5 g/dL

- Creatinine ≤ 1.5 mg/dL

- Total bilirubin ≤ 3 mg/dL

- AST and ALT ≤ 2.0 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.0 times ULN

- Albumin ≥ 2.0 g/dL OR prealbumin ≥ 15 mg/dL

- Magnesium ≥ lower limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- No pre-existing peripheral neuropathy of any etiology ≥ grade 2 (CTCAE V3)

- No prior invasive malignancy, unless disease-free for ≥ 5 years before registration,
except for nonmelanoma skin cancer or in situ cancers

- No uncontrolled intercurrent illness including, but not limited to, any of the

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study

- No history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or
any evidence of interstitial lung disease on baseline chest CT scan

- No history of any medical or psychiatric condition or laboratory abnormality that, in
the opinion of the investigator, may increase the risks associated with the study
participation or investigational product(s) administration or may interfere with the
interpretation of the results


- No prior radiotherapy to chest or upper abdomen

- No prior cisplatin, docetaxel, panitumumab, or other anti-EGFR therapy

- No prior esophageal or gastric surgery

- Prior surgery to treat reflux disease allowed

- No other concurrent antineoplastic or antitumor agents, including chemotherapy,
radiotherapy, immunotherapy, or hormonal anticancer therapy

- No concurrent investigational agents

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete pathologic tumor response

Safety Issue:


Principal Investigator

Carolyn E. Reed, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina


United States: Federal Government

Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • adenocarcinoma of the gastroesophageal junction
  • stage II esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms



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