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

NCT00667420 | Terminated Phase 1 Results

• 1 other identifier: 07326
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophageal Adenocarcinoma; Gastric Adenocarcinoma

Keywords

gastric; esophageal; panitumumab

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Safety and tolerability were measured by assessing the number of participants able to complete 3 cycles of pre-operative chemotherapy

  after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle)

Secondary Outcomes (4)

• R0 Resection Rate

  time of surgery = after 3 cycles (approx 63 days) of pre-operative EOX-P chemotherapy

• Progression-Free Survival

  up to 72 months

• Pathologic Complete Response Rate

  at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days)

• Overall Survival

  duration from enrollment to death (up to 6 years)

Study Arms (1)

EOXP chemotherapy

EXPERIMENTAL

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

Interventions

panitumumab, epirubicin, oxaliplatin, xeloda DRUG

pilot study

EOXP chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

DFCI

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

Panitumumab; Epirubicin; Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

This study was stopped early due to poor tolerability. We will not further study this regimen in this patient population.

Results Point of Contact

• Title: David P. Ryan
• Organization: MassGH

dpryan@partners.org

617-724-0245

Study Officials

• David P Ryan, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, MGH Cancer Center

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2014
• Last Updated: July 4, 2014
• Results First Posted: July 4, 2014

Record last verified: 2014-07

Locations

US (2)