Trial Search Results

Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer.

PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborator: NRG Oncology

Stanford Investigator(s):

Intervention(s):

  • Drug: cetuximab
  • Drug: cisplatin
  • Drug: paclitaxel
  • Radiation: radiation therapy

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   1. Pathologically (histologic or cytologic) proven diagnosis of primary squamous cell or
   adenocarcinoma of the esophagus or gastroesophageal junction within 12 weeks prior to
   registration. Patients with involvement of the gastroesophageal junction with Siewert
   type I or II tumors (tumors arising from the distal esophagus and involving the
   esophagogastric junction or tumors starting at the esophagogastric junction and
   involving the cardia) are eligible.

      - 1.1 Disease must be encompassed in a radiotherapy field.

      - 1.2 Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy
      are eligible.

      - 1.3 Patients with cervical esophageal carcinoma are eligible.

   2. Stage T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a, based upon the following minimum
   diagnostic work-up:

      - 2.1 History/physical examination within 6 weeks prior to registration

      - 2.2 Positron emission tomography (PET)/positron emission tomography-computed
      tomography (PET-CT) scan (strongly recommended) or chest/abdominal CT within 6
      weeks prior to registration

      - 2.3 Electrocardiogram (EKG) within 6 weeks of study entry

      - 2.4 Endoscopy with biopsy or cytology by fine needle aspiration (FNA) (must be
      able to document histologic subtype) within 12 weeks of study entry. Patients
      with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo
      bronchoscopy to exclude fistula. (NOTE: Any images from endoscopic procedures up
      to the time of progression must be kept in the patient's confidential study
      file.)

   3. Zubrod performance status 0-2

   4. Age ≥ 18 and ≤ 74 (upper limit was set at 74 in an amendment)

   5. Complete blood count (CBC)/differential obtained within 2 weeks prior to registration
   on study, with adequate bone marrow function defined as follows:

      - 5.1 Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3

      - 5.2 Platelets ≥ 100,000 cells/mm3

      - 5.3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to
      achieve Hgb ≥8.0 g/dl is acceptable.)

   6. Additional laboratory studies obtained within 2 weeks prior to registration on study

      - 6.1 Creatinine ≤ 1.5 mg/dl

      - 6.2 Bilirubin ≤ 1.5 x upper limit of normal

      - 6.3 Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x
      upper limit of normal

      - 6.4 Serum pregnancy test for women of childbearing potential

   7. Patient's total intake (oral/enteral) must be ≥ 1500 kCal/day

   8. Patient must provide study-specific informed consent prior to study entry

   9. Women of childbearing potential and male participants must practice adequate
   contraception

Exclusion Criteria:

   1. Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
   Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo
   bronchoscopy to exclude fistula.

   2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
   for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity,
   or cervix are all permissible).

   3. Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a
   different cancer is allowable.

   4. Prior radiation therapy that would result in overlap of planned radiation therapy
   fields.

   5. Prior therapy that specifically and directly targets the epidermal growth factor
   receptor (EGFR) pathway.

   6. Prior platinum-based and/or paclitaxel-based therapy.

   7. Prior allergic reaction to the study drugs involved in this protocol.

   8. Prior severe infusion reaction to a monoclonal antibody.

   9. Severe, active comorbidity, defined as follows:

      - 9.1 Unstable angina and/or congestive heart failure requiring hospitalization
      within the last 3 months

      - 9.2 Transmural myocardial infarction within the last 6 months

      - 9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the
      time of registration

      - 9.4 Chronic obstructive pulmonary disease exacerbation or other respiratory
      illness requiring hospitalization or precluding study therapy at the time of
      registration

      - 9.5 Acquired immune deficiency syndrome (AIDS) based upon current Centers for
      Disease Control and Prevention (CDC) definition; note, however, that human
      immunodeficiency virus (HIV) testing is not required for entry into this
      protocol. The need to exclude patients with AIDS from this protocol is necessary
      because the treatments involved in this protocol may be significantly
      immunosuppressive. Protocol-specific requirements may also exclude
      immunocompromised patients.

10. Pregnancy or women of childbearing potential and men who are sexually active and not
   willing/able to use medically acceptable forms of contraception; this exclusion is
   necessary because the treatment involved in this study may be significantly
   teratogenic.

11. Women who are nursing.

Ages Eligible for Study

18 Years - 74 Years

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
Cancer Clinical Trials Office
650-498-7061
Not Recruiting