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

This study has been terminated.
(Closed due to slow accrual)
Sponsor:
Information provided by (Responsible Party):
David Patrick Ryan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00667420
First received: April 24, 2008
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Esophageal Adenocarcinoma
Gastric Adenocarcinoma
Drug: panitumumab, epirubicin, oxaliplatin, xeloda
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

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


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

  • Progression-Free Survival [ Time Frame: up to 72 months ] [ Designated as safety issue: No ]
    measured from the first day of treatment to the day when conclusive evidence of new disease is found

  • Pathologic Complete Response Rate [ Time Frame: at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days) ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: duration from enrollment to death (up to 6 years) ] [ Designated as safety issue: No ]
    Overall survival (OS) is the duration from start of treatment to time of death from any cause.


Enrollment: 17
Study Start Date: April 2008
Study Completion Date: June 2014
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667420

Locations
United States, Massachusetts
DFCI
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David P Ryan, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: David Patrick Ryan, MD, Clinical Director, MGH Cancer Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00667420     History of Changes
Other Study ID Numbers: 07326
Study First Received: April 24, 2008
Results First Received: June 27, 2014
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
gastric
esophageal
panitumumab

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

ClinicalTrials.gov processed this record on November 25, 2014