Clinical Trials Logo

Clinical Trial Summary

Drugs used in chemotherapy such as cisplatin and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs. This phase I/II trial is studying the side effects and best dose of oblimersen when given with cisplatin and fluorouracil and to see how well they work in treating patients with locally advanced, recurrent, or metastatic cancer of the esophagus, gastroesophageal junction, or stomach.


Clinical Trial Description

PRIMARY OBJECTIVES: I. The escalation portion of the study will determine the MTD of G3139/Cisplatin and will help determine the toxicities of this combination. II. Once the MTD is determined, an additional 12 patients will be enrolled in order to obtain a set of tumor biopsies for microarray analysis. SECONDARY OBJECTIVES: I. The collection of additional toxicity data for this combination OUTLINE: This is a pilot, multicenter, dose-escalation study of oblimersen. Phase I: Patients receive oblimersen IV continuously on days 1-7, fluorouracil IV continuously on days 4-8, and cisplatin IV on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 12 patients are treated at the MTD. Phase II: Patients receive treatment as in phase I with oblimersen at the MTD. PROJECTED ACCRUAL: Approximately 37-97 patients (3-36 for phase I and 34-67 for phase II) will be accrued for this study within 15-18 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00064259
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date June 2003
Completion date February 2010

See also
  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 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
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