Adenocarcinoma of the Gastroesophageal Junction Clinical Trial
Official title:
Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma
Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. This phase II trial is studying how well giving oxaliplatin together with irinotecan and capecitabine works in treating patients with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma (cancer).
PRIMARY OBJECTIVES:
I. To assess the total response rate of the oxaliplatin, irinotecan and capecitabine drug
combination in advanced gastric/esophageal junction carcinoma.
II. To assess the duration of total responses of the oxaliplatin, irinotecan and
capecitabine drug combination in advanced gastric/esophageal junction carcinoma.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8,
15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses
repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 18
months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
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 | |
| Completed |
NCT00982592 -
Combination Chemotherapy With or Without Vismodegib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer
|
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 |
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 | |
| Completed |
NCT02443324 -
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
|
Phase 1 |