Trials / Completed
CompletedNCT01561014
Oxaliplatin, Fluorouracil, Erlotinib Hydrochloride, and Radiation Therapy Before Surgery and Erlotinib Hydrochloride After Surgery in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
A Phase I Study of Preoperative Chemoradiation With Oxaliplatin, 5-Fluorouracil, Erlotinib and Radiation Followed by Resection and Consolidative Erlotinib for Patients With Locally Advanced Cancer of the Esophagus and Gastroesophageal Junction
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with oxaliplatin, fluorouracil, and radiation before surgery and alone after surgery in treating patients with locally advanced cancer of the esophagus and gastroesophageal junction. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride 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 combination chemotherapy together with erlotinib hydrochloride and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving erlotinib hydrochloride after surgery may kill any tumor cells that remain after surgery
Detailed description
OBJECTIVES: I. The primary aim of this phase I study is to evaluate the safety of multi-drug chemotherapy (with the addition of an anti-epidermal growth factor receptor \[EGFR\] agent erlotinib \[erlotinib hydrochloride\]) and concomitant radiotherapy followed by resection and consolidative erlotinib for the treatment of locally advanced esophageal cancer as judged by the dose limiting toxicities. Correlative endpoints include an analysis of pre-treatment tumor cyclin D1 expression and EGFR expression/amplification. III. Correlate pathologic complete response with changes in fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)-computed tomography (CT) - pre and post-chemoradiation. OUTLINE: This is a dose escalation study of erlotinib hydrochloride CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily (QD), 5 days a week and receive fluorouracil intravenously (IV) continuously and erlotinib hydrochloride orally (PO) QD on days 1-38. Patients also receive oxaliplatin IV over 2 hours on days 1, 15, and 29. SURGERY: Within 4-8 weeks after completion of chemoradiotherapy, patients with potentially resectable disease (i.e., complete response, partial response, or stable disease) undergo surgery to remove the tumor. CONSOLIDATION CHEMOTHERAPY: Within 2-4 weeks after surgery, patients with tumors that demonstrate positive immunohistochemistry for EGFR and/or cyclin D1 (in the pretreatment biopsy or in the residual tumor in the esophagectomy specimen) receive consolidation chemotherapy comprising erlotinib hydrochloride PO QD for 12 weeks. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Conditions
- Adenocarcinoma of the Esophagus
- Adenocarcinoma of the Gastroesophageal Junction
- Adenocarcinoma of the Stomach
- Squamous Cell Carcinoma of the Esophagus
- Stage II Esophageal Cancer
- Stage II Gastric Cancer
- Stage III Esophageal Cancer
- Stage III Gastric Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | erlotinib hydrochloride | Given PO |
| DRUG | oxaliplatin | Given IV |
| DRUG | fluorouracil | Given IV |
| RADIATION | radiation therapy | Undergo radiotherapy |
| PROCEDURE | conventional surgery | Undergo surgical resection |
| OTHER | immunohistochemistry staining method | Correlative study |
| PROCEDURE | positron emission tomography | Correlative study |
| PROCEDURE | computed tomography | Correlative study |
| PROCEDURE | laboratory biomarker analysis | Correlative study |
| GENETIC | gene expression analysis | Correlative study |
| RADIATION | fludeoxyglucose F 18 | Undergo F18 PET and CT scan |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2012-03-22
- Last updated
- 2018-07-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01561014. Inclusion in this directory is not an endorsement.