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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
N/A
Not Enrolling
Both
Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer

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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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

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

- 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

PRIOR CONCURRENT THERAPY:

- 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:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete pathologic tumor response

Safety Issue:

No

Principal Investigator

Carolyn E. Reed, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Federal Government

Study ID:

CDR0000596674

NCT ID:

NCT00757172

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

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Central Baptist HospitalLexington, Kentucky  40503
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Simmons Cooper Cancer InstituteSpringfield, Illinois  62794-9677
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Good Samaritan HospitalDayton, Ohio  45406
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
Evanston HospitalEvanston, Illinois  60201-1781
Wayne HospitalGreenville, Ohio  45331