Cetuximab, Cisplatin, and Irinotecan in Treating Patients With Metastatic Esophageal Cancer, Gastroesophageal Junction Cancer, or Gastric Cancer That Did Not Respond to Previous Irinotecan and Cisplatin

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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 tumor cells by blocking some of the enzymes needed for their 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. Giving cetuximab together with cisplatin and irinotecan may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin and irinotecan works in treating patients with metastatic esophageal cancer, gastroesophageal junction cancer, or gastric cancer that did not respond to previous irinotecan and cisplatin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Cetuximab; Cisplatin; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• 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 following:

• 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 entry

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

• Positive or negative EGFR by IHC allowed

PATIENT CHARACTERISTICS:

• 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 attenuations

• 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

PRIOR CONCURRENT THERAPY:

• 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