Paclitaxel, Cisplatin, Gefitinib, and Radiation Therapy Followed by Surgery and Gefitinib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction That Can Be Removed By Surgery

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving gefitinib after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving paclitaxel, cisplatin, gefitinib, and radiation therapy followed by surgery and gefitinib works in treating patients with locally advanced cancer of the esophagus or gastroesophageal junction that can be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Gefitinib; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction meeting the following criteria:

• Newly diagnosed disease

• Surgically resectable tumor

• Primary esophageal tumor < 20 cm below the incisors

• Tumor extending ≤ 2 cm into the cardia

• Stage T2-3, N0-1, M0-1a tumor, as determined by imaging studies and biopsy

• Documentation by endoscopic ultrasound, endoscopy, and CT scan of the chest and abdomen required

• Any lesion suspicious for metastasis must be biopsied

• M1a disease (i.e., celiac nodal metastasis) is allowed if other eligibility criteria are met

• T4 disease (i.e., involvement of the pleura, pericardium, or diaphragm) allowed provided it is considered resectable

• No CNS metastasis

• ECOG performance status 0-1

• Granulocyte count > 1,000/mm³

• Platelet count > 75,000/mm³

• Creatinine clearance > 60 mL/min

• Total bilirubin < 1.5 mg/dL

• No concurrent illness likely to preclude protocol therapy or surgical resection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study therapy Exclusion Criteria

• Known severe hypersensitivity to gefitinib or any of its excipients

• Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

• Evidence of other significant clinical disorder or laboratory finding that would preclude study participation

• Evidence of clinically active interstitial lung disease

• Chronic, stable radiographic changes that are asymptomatic are eligible

• Prior or concurrent malignancy except basal cell or squamous cell skin cancer, cervical cancer, or any other curatively treated malignancy from which the patient has been disease-free and has a survival prognosis of > 5 years

• Preexisting peripheral neuropathy > grade 1

• Incomplete healing from prior oncologic or other major surgery

• Prior chemotherapy, radiotherapy, or surgery for this cancer

• More than 30 days since prior nonapproved or investigational drugs

• Concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)

• Concurrent oral retinoids