S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer

Conditions

• Esophageal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cetuximab — BIOLOGICAL
  400mg/m\^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only. 250mg/m\^2 maintenance dose, IV over 60 min, Days 8 \& 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles.
• cisplatin — DRUG
  30mg/m\^2, bolus intravenous (IV), on Days 1 \& 8 of each cycle.
• irinotecan hydrochloride — DRUG
  65mg/m\^2, intravenous (IV) over 30 min, on Days 1 \& 8 of each cycle.
• radiation therapy — RADIATION
  The total dose to the prescription point will be 5,040 cGy given in 28 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter. The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose.

Study Details

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.

Key Dates

Start date

May 31, 2005

Status verified

Nov 2015

Primary completion

Sep 30, 2009

Completion

May 31, 2012

Study Design

Enrollment

22 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
  Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3.

Primary Outcome Measure

Overall Survival at 2 Years [ Time Frame: 0-2 years ]

Locations (132)

Find similar trials in Mobile, AL

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