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

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01142388

Run by

National Cancer Institute (NCI)

People needed

94

Starts

2010-09-21

Expected to finish

2027-03-31

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• CommonSpirit Saint Anthony Hospital Cancer Center — 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 Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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