Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
Condition: Esophageal Carcinoma
MeSH terms: Carcinoma; Esophageal Neoplasms
Intervention: Cisplatin; Irinotecan; External Beam Radiation Therapy
Intervention description: pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12; Irinotecan will be given 65 mg/m2; will be delivered with multiple (>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.
Intervention MeSH terms: Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Esophageal Carcinoma; Cisplatin; Irinotecan; Radiation Therapy; 02-045

Summary:

      Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive
      six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4
      and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy
      with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of
      radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of
      chemoradiotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be able to sign the informed consent document.

        Exclusion Criteria:

          -  Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy,
             endoscopic ultrasound, or CT scanning.

          -  Cervical esophageal tumors,

          -  Gastric cancers with minor involvement of the gastroesophageal junction or distal
             esophagus.

          -  Prior chemotherapy or radiation.

          -  Patients with evidence of metastatic disease are not eligible. This includes:

          -  Positive malignant cytology of the pleura, pericardium or peritoneum.

          -  Radiographic evidence of distant organ involvement including lung, liver, bone, or
             brain.

          -  Patients with involvement of non-regional lymph nodes including supraclavicular or
             celiac lymph node metastases.

          -  Biopsy proven tumor invasion of the tracheobronchial tree or presence of
             tracheoesophageal fistula. Recurrent laryngeal nerve or phrenic nerve paralysis,

          -  New York Heart Association Class III or 1V heart disease. Angina or myocardial
             infarction within the last 6 months, history of significant ventricular arrhythmia
             requiring medication with antiarrhythmics, or a history of a clinically significant
             conduction system abnormality.

          -  Severe co-morbid conditions including severe uncontrolled diabetes, uncontrolled
             hypertension, cerebral vascular disease, uncontrolled infection, or nonmalignant
             illness whose control may be jeopardized by the complications of this study treatment.

          -  Pregnant or lactating women are ineligible as the effect of the drugs used in this
             study on a fetus or newborn child are unknown. Premenopausal fertile females require a
             negative pregnancy test prior to study entry. Treatment may not begin until the
             results of the pregnancy tests are ascertained. Both sexes must use contraception
             while on this study.

          -  History of prior malignancy (other than basal cell/squamous carcinoma of the skin,
             in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma)
             diagnosed and/or treated within three years of entrance into this study.

          -  Patients with known Gilbert's Disease.

          -  Clinically significant hearing loss.

          -  Serum calcium_>12 mg/dl.

          -  Patients with a history of seizure disorder who are receiving phenytoin,
             phenobarbital, or other antiepileptic medication.

          -  Patients who cannot fully comprehend the therapeutic implications of the protocol or
             comply with the requirements.

          -  Patients with any other concurrent medical or psychiatric condition or disease, which,
             in the investigator's judgment, would make the patient inappropriate for entry into
             this study.