Stage IV Gastric Cancer Clinical Trial
Official title:
An Evaluation of Preoperative Chemotherapy With Irinotecan and Cisplatin for Advanced, But Resectable Gastric Cancer: A Coordinated Multidisciplinary, Multicenter Study Linking Functional Imaging, Genomic Expression Profiles and Histopathology
This phase II trial is studying how well giving irinotecan together with cisplatin works in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them before surgery may shrink the tumor so that it can be removed during surgery.
PRIMARY OBJECTIVES:
I. To evaluate the correlation of FDG-PET/CT imaging early in the preoperative treatment
program of locally advanced gastric cancer with histologic response assessment and patient
outcome, defined as overall and progression-free survival.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy and safety of preoperative chemotherapy with irinotecan and
cisplatin in the treatment of locally advanced gastric cancer.
II. To examine the biology of locally advanced gastric cancer and the response to
chemotherapy by DNA microarray technology and by histopathology.
III. To obtain preliminary data on biodistribution, dosimetry and explore the potential
clinical usefulness of FLT PET in patients with locally advanced gastric cancer undergoing a
novel combination neoadjuvant chemotherapy.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by
irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for
2 courses in the absence of disease progression or unacceptable toxicity.
Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo
radical subtotal or total gastrectomy with lymph node dissection.
Patients undergo fluorodeoxyglucose FDG-PET/CT at baseline. Some patients undergo additional
FDG-PET/CT scans in weeks 3 and 6. Approximately 5 patients undergo fluorothymidine
FLT-PET/CT at baseline, during week 3, and/or before surgical resection.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
annually thereafter.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
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 | |
| 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 |
NCT00068380 -
A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
|
Phase 2 | |
| Completed |
NCT00084617 -
Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma
|
Phase 2 |