Stanford APBI Trial

Clinical Trial

Overview

Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.

Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.

Currently, women with breast cancer who undergo a lumpectomy  typically have 6 1/2 weeks of radiation to the entire affected breast after surgery.  Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.

In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.

APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI  worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.

Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:

    Intraoperative Radiotherapy (IORT) - 1 day

    Intracavitary Brachytherapy (MammoSite) - 5 days

    3-D Conformal/External Beam Radiotherapy - 5 days

The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.

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

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.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • biological: cixutumumab
  • drug: paclitaxel
  • other: laboratory biomarker analysis
  • other: pharmacological study

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

What's New

Stanford’s APBI trial has now been expanded to include women with  ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.