Perioperative Panitumumab and Epirubicin, Oxaliplatin and Xeloda (EOX) in Patients With Gastroesophageal Adenocarcinoma (EOXP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00667420
Recruitment Status : Terminated (Closed due to slow accrual)
First Posted : April 28, 2008
Results First Posted : July 4, 2014
Last Update Posted : July 4, 2014
Information provided by (Responsible Party):
David Patrick Ryan, MD, Massachusetts General Hospital

Brief Summary:
A pilot study to determine the safety of using perioperative panitumumab with EOX (epirubicin, oxaliplatin, and capecitabine) in patients with adenocarcinoma of the esophagus and stomach.

Condition or disease Intervention/treatment Phase
Esophageal Adenocarcinoma Gastric Adenocarcinoma Drug: panitumumab, epirubicin, oxaliplatin, xeloda Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Perioperative Panitumumab in Combination With Epirubicin, Oxaliplatin and Xeloda in Patients With Resectable Gastroesophageal Adenocarcinoma
Study Start Date : April 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: EOXP chemotherapy
open-label, single-arm EOXP Epirubicin 50mg/m2 by IV on day 1 of each 21 day cycle, Oxaliplatin 100 mg/m2 by IV on day 1 of each 21 day cycle, Capecitabine 400 mg/m2 twice daily by mouth on days 1-21 of the 21 day cycle Panitumumab - 9mg/kg by IV on day 1 of each 21 day cycle
Drug: panitumumab, epirubicin, oxaliplatin, xeloda
pilot study

Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle) ]
    Safety and tolerability were measured by assessing the number of participants able to complete 3 cycles of pre-operative chemotherapy

Secondary Outcome Measures :
  1. R0 Resection Rate [ Time Frame: time of surgery = after 3 cycles (approx 63 days) of pre-operative EOX-P chemotherapy ]
    percentage of participants who have microscopically negative margins (no tumor at/near the edge of what is resected) at the time of surgical resection

  2. Progression-Free Survival [ Time Frame: up to 72 months ]
    measured from the first day of treatment to the day when conclusive evidence of new disease is found

  3. Pathologic Complete Response Rate [ Time Frame: at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days) ]
    For patients who undergo complete resection, those who have no evidence of residual viable tumor in the surgical specimen will be declared to have achieved a complete pathologic response (pCR), and the overall percentage of patients with pCR will be determined.

  4. Overall Survival [ Time Frame: duration from enrollment to death (up to 6 years) ]
    Overall survival (OS) is the duration from start of treatment to time of death from any cause.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed diagnosis of adenocarcinoma of the stomach, gastroesophageal junction, or lower third of the esophagus, AJCC stage II-IIIB (gastric) or IIA-IVA (esophageal). M1a disease will be included, but not T4 lesions.
  • No prior radiation or chemotherapy including anti-EGFR or vascular endothelial growth factor (VEGF) antibody or tyrosine kinase inhibitor treatments.
  • All patients must have staging endoscopic ultrasound (EUS) prior to enrollment.
  • Men or Women >18 years of Age
  • ECOG performance status <2 (Karnofsky >60%, see Appendix A).
  • Cardiac ejection fraction >45% by echocardiogram or MUGA scan.
  • Must be able to either swallow pills or have gastrostomy tube in place for administration of enteral medications.
  • Patients must have normal organ, metabolic and marrow function as defined below:

    • Hematologic function, as follows:

      • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
      • Platelet count ≥ 100 x 109/L
      • Hemoglobin ≥ 9.0 g/dL
    • Renal function, as follows:

      • Creatinine < or = 1.5 mg/dL x ULN

Hepatic function, as follows:

  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)< or = 3 x ULN
  • Total bilirubin < 1.5 x ULN

Metabolic function, as follows:

  • Magnesium ≥ lower limit of normal
  • Calcium < or = lower limit of normal -Human IgG is known to cross the placental barrier; therefore, Panitumumab may be transmitted from the mother to the developing fetus. In women of childbearing potential, appropriate contraceptive measures must be used during treatment with panitumumab and for 6 months following the last dose of panitumumab. If panitumumab is used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential risk for loss of the pregnancy or potential hazard to the fetus.

3.1.10 Ability to understand and the willingness to sign and date a written IEC/IRB approved informed consent form.

Exclusion Criteria:

  • Evidence of distant metastatic disease.
  • T4 tumor on initial staging studies.
  • History of another primary cancer, except:
  • Curatively treated in situ cervical cancer
  • Curatively resected non-melanoma skin cancer
  • Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ³ 5 years prior to enrollment
  • Relative or absolute contraindications to surgery which in the opinion of the investigator make the patient a poor candidate for surgical resection.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to panitumumab or other agents used in study.
  • Subjects requiring chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan.
  • 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.
  • Subject unwilling or unable to comply with study requirements.
  • Women who test positive for serum or urine pregnancy test < 72 hours before randomization or are breast feeding.
  • Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection.
  • Major surgery with 28 days or minor surgery within 14 days of study enrollment.
  • Men or women of child-bearing potential (women who are post-menopausal < 52 weeks, not surgically sterilized, or not abstinent) not consenting to use adequate contraception (per institutional standard of care) during the course of the study and after the last investigational product(s) administration (24 weeks for women, 4 weeks for men).
  • Subjects with > grade 1 neuropathy at baseline.
  • Contraindication to port-a-cath placement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00667420

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: David P Ryan, MD Massachusetts General Hospital

Responsible Party: David Patrick Ryan, MD, Clinical Director, MGH Cancer Center, Massachusetts General Hospital Identifier: NCT00667420     History of Changes
Other Study ID Numbers: 07326
First Posted: April 28, 2008    Key Record Dates
Results First Posted: July 4, 2014
Last Update Posted: July 4, 2014
Last Verified: July 2014

Keywords provided by David Patrick Ryan, MD, Massachusetts General Hospital:

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic