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Phase II Trial of Cetuximab Plus Cisplatin and Irinotecan in Patients With Irinotecan and Cisplatin-Refractory Metastatic Esophageal and Gastric Cancer

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Gastric Cancer

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Trial Information

Phase II Trial of Cetuximab Plus Cisplatin and Irinotecan in Patients With Irinotecan and Cisplatin-Refractory Metastatic Esophageal and Gastric Cancer



- Determine the response rate in patients with irinotecan hydrochloride- and
cisplatin-refractory metastatic esophageal, gastroesophageal junction, or gastric
cancer treated with cetuximab, cisplatin, and irinotecan hydrochloride.


- Determine the median survival of patients treated with this regimen.

- Determine the tolerability of this regimen in these patients.

- Determine the adverse event profiles in patients treated with this regimen.

- Assess epidermal growth factor receptor expression in tumor tissue from patients
treated with this regimen.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and cisplatin IV over
30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8. Treatment
repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor biopsy at baseline to evaluate epidermal growth factor receptor by

After completion of study treatment, patients are followed every 3 months for up to 1 year.

Inclusion Criteria


- Histologically or cytologically confirmed diagnosis of 1 of the following:

- Adenocarcinoma or squamous cell carcinoma of the esophagus

- Adenocarcinoma of the gastroesophageal junction

- Adenocarcinoma of the stomach

- Metastatic disease

- Measurable disease by diagnostic CT scan or MRI

- Failed prior treatment with cisplatin and irinotecan hydrochloride, defined by the

- Radiographic progression within 12 weeks* from the last dose of prior cisplatin
and irinotecan hydrochloride, administered either as adjuvant or neoadjuvant
therapy, OR as therapy for metastatic disease NOTE: *Prior irinotecan
hydrochloride and cisplatin must have been administered within the past 12
weeks; other chemotherapy regimens may have been administered between the time
of disease progression or prior irinotecan hydrochloride/cisplatin and study

- Pathologic tissue available for immunohistochemistry (IHC) staining for the epidermal
growth factor receptor (EGFR)

- Positive or negative EGFR by IHC allowed


- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

- Life expectancy > 3 months

- WBC ≥ 3,000/mm³

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9 g/dL

- Bilirubin normal

- AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases
are present)

- Creatinine ≤ 2.0 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior severe infusion reaction to a monoclonal antibody

- No history of allergic reactions to compounds of similar chemical or biologic
composition to irinotecan hydrochloride, cisplatin, or other study agents

- No prior intolerance to irinotecan hydrochloride or cisplatin despite prior dose

- No uncontrolled illness including, but not limited to, any of the following:

- Ongoing or active infection requiring parenteral antibiotics

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Uncontrolled hypertension

- Clinically significant cardiac arrhythmia

- Myocardial infarction within the past 6 months

- HIV infection

- Psychiatric illness or social situations that would preclude study compliance

- No history of Gilbert's disease

- No medical condition or reason that would preclude study treatment


- See Disease Characteristics

- More than 3 weeks since prior chemotherapy or radiotherapy and recovered

- No more than 2 prior treatment regimens for metastatic disease

- No prior therapy specifically and directly targeting the epidermal growth factor
receptor pathway

- No prior anticancer murine or chimeric monoclonal antibody therapy

- Prior humanized monoclonal antibody therapy allowed

- No concurrent antiseizure medications known to affect the metabolism of irinotecan
hydrochloride, including phenytoin or phenobarbital

- No other concurrent investigational agents

- No other concurrent anticancer agents or therapies

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete and partial response rate

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

David H. Ilson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2006

Completion Date:

September 2010

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
  • recurrent esophageal cancer
  • recurrent gastric cancer
  • adenocarcinoma of the stomach
  • stage IV esophageal cancer
  • stage IV gastric cancer
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021