Adenocarcinoma of the Gastroesophageal Junction Clinical Trial
Official title:
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
Verified date | June 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 9 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Newly diagnosed patients with locally advanced esophageal cancer with either squamous or adenocarcinoma histology; patients should have evidence of extension of disease into or through the wall of the esophagus (T2-4) and/or regional nodal metastasis (N1) - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Non-pregnant; patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method); nursing mothers are also ineligible - Prior treatment: Greater than one week shall have elapsed since any major surgery; no prior chemotherapy or radiotherapy is allowed - Adequate whole blood cell (WBC) and platelets (Plt) as determined by medical oncology - Serum creatinine =< 1.5 mg/dl - Creatinine clearance >= 60 ml/min - Hemoglobin (Hgb) >= 9.0 gm/dl - Absolute neutrophil count >= 1,500/uL - Serum total bilirubin =< 1.5 mg/dL - Alkaline phosphatase =< 3X the upper limit of normal (ULN) for the reference lab - Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than 2X ULN for the reference laboratory - Patients must be told of the investigational nature of the study and must sign a written informed consent - No serious medical or psychiatric illnesses which would prevent informed consent or otherwise limit survival to less than two years; no history of refractory congestive heart failure or cardiomyopathy - Patients should be evaluated by medical oncology, radiation oncology, and surgery, and felt to by all to be suitable for trimodality therapy Exclusion Criteria: Patients with an active infection or with a fever >= 38.5 degrees Celsius (C) within 3 days of the first scheduled day of protocol treatment - History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate surface antigen (PSA) of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry - Patients with known hypersensitivity to any of the components of oxaliplatin - Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication) - Peripheral neuropathy >= Grade 2 - History of allogeneic transplant - Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both) - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity rate of combination chemotherapy followed by surgery and erlotinib hydrochloride | Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting (CTCAE v3.0). The dose limiting toxicity will be defined as any of the following that can be attributal to therapy: Any grade 4 neutropenia and or any grade 4 thrombocytopenia, or any >= grade 3 non-hematologic toxicity that results in a greater than 3 day interruption of therapy. | Approximately 6 months | |
Secondary | Time to progression | Approximately 4 years | ||
Secondary | Survival | Approximately 4 years | ||
Secondary | Specific characteristics that predict complete response rate (e.g., EGFR status, EGFR amplification, and cyclin D1 expression) | Over 4 years | ||
Secondary | Specific characteristics that predict complete response rate (e.g., EGFR status, EGFR amplification, and cyclin D1 expression) | Approximately 1 year | ||
Secondary | Test the predictive value of FDG-PET-CT imaging in identifying patients who will have a complete response | Approximately 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02234180 -
Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery
|
Phase 2 | |
Terminated |
NCT01705340 -
Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery
|
Phase 1 | |
Completed |
NCT01178944 -
Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
|
Phase 2 | |
Completed |
NCT00982592 -
Combination Chemotherapy With or Without Vismodegib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer
|
Phase 2 | |
Completed |
NCT00991952 -
Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach or Gastroesophageal Junction Cancer That Cannot Be Removed By Surgery
|
Phase 2 | |
Terminated |
NCT00732745 -
Vandetanib, Oxaliplatin, and Docetaxel in Advanced Cancer of the Esophagus or Gastroesophageal Junction
|
Phase 1 | |
Completed |
NCT00253370 -
Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer
|
Phase 2 | |
Recruiting |
NCT04773769 -
Study of Guanábana Leaves for The Treatment of Patients With Gastric, Gastroesophageal Junction, Pancreatic and Colorectal Adenocarcinomas; Hepatocellular Carcinoma, and Low Grade Lymphomas
|
N/A | |
Completed |
NCT02918162 -
Perioperative Chemo and Pembrolizumab in Gastric Cancer
|
Phase 2 | |
Completed |
NCT01612546 -
Pilot Trial of CRLX101 in Treatment of Patients With Advanced or Metastatic Stomach, Gastroesophageal, or Esophageal Cancer That Cannot be Removed by Surgery
|
Phase 2 | |
Active, not recruiting |
NCT01939275 -
64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer
|
N/A | |
Completed |
NCT02013154 -
A Study of DKN-01 in Combination With Paclitaxel or Pembrolizumab
|
Phase 1 | |
Completed |
NCT01107639 -
Radiation Therapy and Chemotherapy, With or Without Cetuximab, Followed by Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery
|
Phase 3 | |
Completed |
NCT01855854 -
Second-line Treatment With Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression (IHC 3+) or Positive FISH
|
Phase 2 | |
Withdrawn |
NCT02344810 -
C-Met Inhibitor AMG 337, Oxaliplatin, Leucovorin Calcium, and Fluorouracil in Treating Patients With Advanced Stomach or Esophageal Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01243398 -
Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy
|
Phase 3 | |
Completed |
NCT00084617 -
Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma
|
Phase 2 | |
Completed |
NCT01360086 -
Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction
|
Phase 2 | |
Terminated |
NCT00064259 -
A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00045526 -
Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
|
Phase 2 |