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

Official record

Identifier

NCT01142388

Recruiting locations

country

United States

Interventions studied

CixutumumabLaboratory Biomarker AnalysisPaclitaxelPharmacological Study

Lead sponsor

National Cancer Institute (NCI)

Target enrolment

94 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Active, not recruiting

First posted

Jun 11, 2010

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Esophageal Cancer