A Study of Paclitaxel with or without Cixutumumab as Second-Line Therapy for Treating Patients with Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 10-007765
    • Jacksonville, Florida: 10-007765
    • Rochester, Minnesota: 10-007765
    NCT ID: NCT01142388
    Sponsor Protocol Number: E2208

About this study

The purpose of this study is to assess how well paclitaxel, with or without cixutumumab, works for treating patients who have esophageal cancer or gastroesophageal junction cancer that has spread to other places in the body. 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Life expectancy ≥ 12 weeks
  • 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
  • Females of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method or birth control, or abstinence) for the duration of study therapy and for 3 months after the last dose of cixutumumab (IMC-A12)
    • If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately
  • Must have measurable disease
  • 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
    • For the purposes of this study
      • Undifferentiated adenocarcinomas and adenosquamous tumors will be considered as adenocarcinomas
      • Tumors involving the gastroesophageal junction will be defined by the Siewert classification
    • Gastroesophageal junction tumors that 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
    • Gastroesophageal junction tumors that are NOT eligible
      • AEG Type III
        • Subcardial gastric carcinoma which infiltrates the esophagogastric junction and distal esophagus from below
    • Must have received and progressed on one and only one line of prior systemic therapy for esophagus or esophagogastric cancer
    • Could have included one regimen for metastatic disease, or one regimen with radiotherapy for initially locally advanced disease
    • Prior radiation therapy is permitted
      • For progress or recurrance within 6 months of neoadjuvant/adjuvant therapy this will be considered one line of therapy
      • For progression or recurrance more than 6 months after neoadjuvant/adjuvant therapy will need to receive one line of therapy for the recurrent disease
      • If receive one regimen in which a chemotherapy agent is dropped for toxicity without progression, this treatment will be considered one line of therapy
      • 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
  • 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
    • Not considered to have a currently active malignancy if have completed therapy and are considered by their physician to be at less than 30% risk of relapse

Exclusion Criteria

  • Has received prior taxane or anti-insulin growth factor receptor (IGFR) therapy
  • Must not have any of the following conditions
    • Poorly controlled diabetes mellitus
      • History of diabetes mellitus allowed provided 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 there is 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Harry Yoon, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Harry Yoon, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Harry Yoon, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20314930

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