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

Gastric Adenocarcinoma Clinical Trial

— EOXP  

Official title:

A Pilot Study of Perioperative Panitumumab in Combination With Epirubicin, Oxaliplatin and Xeloda in Patients With Resectable Gastroesophageal Adenocarcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00667420
• Other study ID #: 07326
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: April 24, 2008
• Last updated: July 3, 2014
• Start date: April 2008
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: June 2014
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Adenocarcinoma
• Esophageal Neoplasms
• Gastric Adenocarcinoma

Intervention

Drug:
• panitumumab, epirubicin, oxaliplatin, xeloda
pilot study

Locations

Country	Name	City	State
United States	DFCI	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	R0 Resection Rate	percentage of participants who have microscopically negative margins (no tumor at/near the edge of what is resected) at the time of surgical resection	time of surgery = after 3 cycles (approx 63 days) of pre-operative EOX-P chemotherapy	No
Secondary	Progression-Free Survival	measured from the first day of treatment to the day when conclusive evidence of new disease is found	up to 72 months	No
Secondary	Pathologic Complete Response Rate	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.	at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days)	No
Secondary	Overall Survival	Overall survival (OS) is the duration from start of treatment to time of death from any cause.	duration from enrollment to death (up to 6 years)	No