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

NCT00397904 | Completed Phase 2 Results

• 3 other identifiers: 06-095P30CA008748MSKCC-06095
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer; Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Complete and Partial Response Rate

  2 years

Study Arms (1)

Cetuximab, Cisplatin, and Irinotecan

EXPERIMENTAL

Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.

Biological: cetuximab; Drug: cisplatin; Drug: irinotecan hydrochloride; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: biopsy

Interventions

cetuximab BIOLOGICAL

Cetuximab, Cisplatin, and Irinotecan

cisplatin DRUG

Cetuximab, Cisplatin, and Irinotecan

irinotecan hydrochloride DRUG

Cetuximab, Cisplatin, and Irinotecan

immunohistochemistry staining method OTHER

Cetuximab, Cisplatin, and Irinotecan

laboratory biomarker analysis OTHER

Cetuximab, Cisplatin, and Irinotecan

biopsy PROCEDURE

Cetuximab, Cisplatin, and Irinotecan

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Cetuximab; Cisplatin; Irinotecan; Immunohistochemistry; Biopsy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. David Ilson
• Organization: Memorial Sloan Kettering Cancer Center

ilsond@mskcc.org

646-888-4183

Study Officials

• David H. Ilson, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: October 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 25, 2015
• Results First Posted: November 25, 2015

Record last verified: 2015-10

Locations

US (1)