Stage IV Gastric Cancer Clinical Trial
Official title:
Phase II Study of GW572016 (NSC-727989) as First Line Therapy in Patients With Advanced or Metastatic Gastric Cancer
This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic stomach cancer. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES:
I. To assess the confirmed response (complete and partial) probability in patients with
advanced/metastatic gastric cancer treated with GW572016.
II. To assess the time to treatment failure and overall survival in this group of patients.
III. To assess the qualitative and quantitative toxicities associated with this regimen.
IV. To assess, in a preliminary manner, the relationship of protein expression and gene
expression of EGFR, HER2 and markers of angiogenesis with clinical outcomes in patients
treated with GW572016.
OUTLINE: This is a multicenter study.
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
;
Endpoint Classification: Safety/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 |
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 | |
| Completed |
NCT00068380 -
A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
|
Phase 2 |