Nitrocamptothecin in Treating Patients With Locally Advanced or Metastatic Stomach Cancer That Cannot Be Removed During Surgery
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally advanced or metastatic stomach cancer that cannot be removed during surgery.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of RFS 2000 (Rubitecan, 9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Gastric Carcinoma|
|Study Start Date:||April 2000|
OBJECTIVES: I. Determine the objective response rate, progression-free survival, overall survival, and time to treatment failure in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with oral nitrocamptothecin. II. Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to prior therapy (yes vs no). Patients receive oral nitrocamptothecin on days 1-5. Treatment repeats every week for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after week 8 may receive additional courses of therapy. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 21-55 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005876
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Show-Li Sun, MD||Astex Pharmaceuticals|