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

Not Recruiting

Trial ID: NCT01142388


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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor


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

   - 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

   - 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

   - 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)

   - 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


biological: cixutumumab

drug: paclitaxel

other: laboratory biomarker analysis

other: pharmacological study

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

New Trial Alerts