Study of 5-FU, Oxaliplatin, & Lapatinib Combined With Radiation Therapy to Treat HER2 Positive Esophagogastric Cancer

Conditions

• HER2 Positive Esophagogastric Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 5-Fluorouracil — DRUG
  5-FU, 225 mg/m2 IVCI, during XRT.
• Oxaliplatin — DRUG
  Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
• Lapatinib — DRUG
  Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
• Radiation Therapy — RADIATION
  Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6

Study Details

With improvements in response rate and survival seen for HER2 positive patients treated with HER2 blockade in the metastatic setting, the use of HER2 blockade in the neoadjuvant setting to increase antitumor effect shows promise. Patients with previously untreated localized HER2 positive esophageal, GE junction and gastric adenocarcinomas will be enrolled. Patients meeting all inclusion/exclusion criteria will receive neoadjuvant treatment with concurrent chemotherapy and radiation therapy beginning on day 1 of treatment. During the lead-in safety portion, the optimal dose of lapatinib will be determined.

Key Dates

Start date

Feb 28, 2013

Status verified

May 2016

Primary completion

Feb 28, 2014

Completion

Feb 28, 2015

Study Design

Enrollment

12 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Combined Therapy
  Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery

Primary Outcome Measure

Pathologic Complete Response Rate (pCR Rate) [ Time Frame: 18 months ]

Locations (9)

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