A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer

Status Completed

Clinical Trial Summary

Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. This phase II trial is studying how well imatinib mesylate works in treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the response rate, time to tumor progression, and overall survival in patients with metastatic gastric cancer treated with STI571 who have failed one chemotherapy regimen for metastatic disease.

II. To assess the toxicities of STI571 in these patients. III. To obtain preliminary data on molecular correlates to determine clinical efficacy and toxicity.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk [chemonaïve] vs poor risk [1 prior chemotherapy regimen]).

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 1-1.5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00068380
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 2
Start date	March 2004
Completion date	March 2010

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02291211` - S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis	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
Completed	`NCT01846520` - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers	N/A
Completed	`NCT01191684` - Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer	Phase 1
Terminated	`NCT01233505` - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors	Phase 1
Completed	`NCT00006389` - Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer	Phase 2
Terminated	`NCT01249443` - Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection	Phase 1
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
Completed	`NCT00028496` - Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer	Phase 1
Active, not recruiting	`NCT01939275` - 64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer	N/A
Active, not recruiting	`NCT01637805` - Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer	Phase 1
Terminated	`NCT00087191` - EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer	N/A
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	`NCT01643499` - Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies	Phase 1
Completed	`NCT01839773` - A Phase 3 Study to Compare Efficacy and Safety of DHP107 Versus Taxol® in Patients With Metastatic or Recurrent Gastric Cancer After Failure of First-line Chemotherapy	Phase 3
Completed	`NCT00084617` - Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma	Phase 2
Terminated	`NCT00064259` - A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer	Phase 1/Phase 2