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ACTIVE NOT RECRUITING

NCT01142388

PHASE2

Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase II trial studies how well paclitaxel with or without cixutumumab works in treating patients with esophageal cancer or gastroesophageal junction cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cixutumumab may kill cancer cells by blocking the action of a protein needed for cancer cell growth. Giving paclitaxel with or without cixutumumab may kill more tumor cells.

Official title: Randomized Phase II Study of Paclitaxel With or Without the Anti-IGF-IR mAb Cixutumumab (IMC-A12) as Second Line Treatment for Patients With Metastatic Esophageal or GE Junction Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2010-09-21

Completion Date

2026-03-19

Last Updated

2025-11-25

Healthy Volunteers

Conditions

Metastatic Esophageal Adenocarcinoma Metastatic Esophageal Squamous Cell Carcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Recurrent Esophageal Adenocarcinoma Recurrent Esophageal Carcinoma Recurrent Esophageal Squamous Cell Carcinoma Recurrent Gastroesophageal Junction Adenocarcinoma Stage IV Esophageal Cancer AJCC v7

Interventions

BIOLOGICAL

Cixutumumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel

Given IV

OTHER

Pharmacological Study

Correlative studies

Inclusion Criteria: * Life expectancy \>= 12 weeks * Women must not be pregnant or breast-feeding due to potential harm to fetus from cixutumumab (IMC-A12) and paclitaxel; all females of childbearing potential must have a blood test or urine study within 48 hours prior to registration to rule out pregnancy * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method or birth control; abstinence) for the duration of study therapy and for 3 months after the last dose of cixutumumab (IMC-A12); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Patients must have measurable disease * Patients must have metastatic disease of the esophagus or gastroesophageal junction * Histologic, cytologic or radiologic documentation of metastatic squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction; radiologic, endoscopic, histologic or cytologic evidence of locally recurrent or locally residual (post-resection) disease is also permitted * For the purposes of this study, undifferentiated adenocarcinomas and adenosquamous tumors will be considered as adenocarcinomas; in addition, tumors involving the gastroesophageal junction will be defined by the Siewert classification * Patients with gastroesophageal junction tumors who are eligible: * Adenocarcinoma of the esophageal junction (AEG) Type I: adenocarcinoma of the distal esophagus which usually arises from an area with specialized intestinal metaplasia of the esophagus, i.e., Barrett's esophagus, and may infiltrate the esophagogastric junction from above * AEG Type II: true carcinoma of the cardia arising from the cardiac epithelium or short segments with intestinal metaplasia at the esophagogastric junction * Patients with gastroesophageal junction tumors who are NOT eligible: * AEG Type III: subcardial gastric carcinoma which infiltrates the esophagogastric junction and distal esophagus from below * Patients must have received and progressed on one and only one line of prior systemic therapy for esophagus or esophagogastric cancer; this could have included one regimen for metastatic disease, or one regimen with radiotherapy for initially locally advanced disease; prior radiation therapy is permitted * If patients progress or recur within 6 months of neoadjuvant/adjuvant therapy, this will be considered one line of therapy; for patients progressing or recurring more than 6 months after neoadjuvant/adjuvant therapy, they will need to receive one line of therapy for recurrent disease to be eligible * If patients receive one regimen in which a chemotherapy agent is dropped for toxicity without progression, this treatment will be considered one line of therapy; however, substitution or addition of a new agent will be considered a second line of therapy * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Leukocytes \> 3,000/mcL * Absolute neutrophil count \>= 1,500/mcL * Hemoglobin \>= 9 g/dL * Platelets \>= 100,000/mcL * Total bilirubin =\< institutional upper limit of normal (ULN) * Aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine transaminase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 X institutional ULN * Creatinine =\< 1.5 X institutional ULN or creatinine clearance \>= 60 mL/min/1.73m\^2 for patients with creatinine levels above institutional normal * Patients must have fasting serum glucose =\< 160 mg/dL (8.8 mmol/L) or =\< ULN, and hemoglobin A1C =\< 7% (0.07 International System of Units \[SI units\]) within 14 days of registration; if baseline nonfasting glucose =\< 160 mg/dL (8.8 mmol/L), fasting glucose measurement is not required * Registration no fewer than 28 days from last chemotherapy * A "currently active" second malignancy other than non-melanoma skin cancers are not to be registered; patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse Exclusion Criteria: * Patients have received prior taxane or anti-insulin growth factor receptor (IGFR) therapy * Patients must not have any of the following conditions: * Poorly controlled diabetes mellitus; patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting glucose =\< 160 mg/dL \[8.8 mmol/L\] or below the ULN and hemoglobin A1C =\< 7% \[0.07 SI units\]) and that they are on a stable dietary or therapeutic regimen for this condition * Recent major surgery, hormonal therapy (other than replacement) or chemotherapy, within 4 weeks prior to entering the study or those who have not recovered from adverse events * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cixutumumab (IMC-A12) * Psychiatric illness that would prevent the patient from giving informed consent * Medical conditions such as active/uncontrolled infection (including HIV) or cardiac disease that would make this protocol unreasonably hazardous for the patient in the opinion of the treating physician; cardiac disease may include uncontrolled high blood pressure, unstable angina, or serious uncontrolled cardiac arrhythmia

Locations (233)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Western States Cancer Research NCORP

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

AdventHealth Littleton

Littleton, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Rush-Copley Medical Center

Aurora, Illinois, United States

MacNeal Hospital and Cancer Center

Berwyn, Illinois, United States

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Graham Hospital Association

Canton, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

Hematology and Oncology Associates

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Eureka Hospital

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Mason District Hospital

Havana, Illinois, United States

Hematology Oncology Associates of Illinois-Highland Park

Highland Park, Illinois, United States

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, United States

Duly Health and Care Joliet

Joliet, Illinois, United States

Presence Saint Mary's Hospital

Kankakee, Illinois, United States

AMG Libertyville - Oncology

Libertyville, Illinois, United States

Mcdonough District Hospital

Macomb, Illinois, United States

Trinity Medical Center

Moline, Illinois, United States

DuPage Medical Group-Ogden

Naperville, Illinois, United States

Illinois Cancer Specialists-Niles

Niles, Illinois, United States

Carle BroMenn Medical Center

Normal, Illinois, United States

Carle Cancer Institute Normal

Normal, Illinois, United States

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, United States

Proctor Hospital

Peoria, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois Valley Hospital

Peru, Illinois, United States

Perry Memorial Hospital

Princeton, Illinois, United States

West Suburban Medical Center

River Forest, Illinois, United States

Swedish American Hospital

Rockford, Illinois, United States

Hematology Oncology Associates of Illinois - Skokie

Skokie, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Elkhart General Hospital

Elkhart, Indiana, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Richard L. Roudebush Veterans Affairs Medical Center

Indianapolis, Indiana, United States

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

IU Health Central Indiana Cancer Centers-East

Indianapolis, Indiana, United States

Community Howard Regional Health

Kokomo, Indiana, United States

IU Health La Porte Hospital

La Porte, Indiana, United States

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, United States

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, United States

IU Health Ball Memorial Hospital

Muncie, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

McFarland Clinic - Ames

Ames, Iowa, United States

Mercy Hospital

Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Iowa Methodist Medical Center