S9915 Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach
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|ClinicalTrials.gov Identifier: NCT00004233|
Recruitment Status : Completed
First Posted : August 25, 2003
Last Update Posted : July 25, 2011
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of triacetyluridine, fluorouracil, and leucovorin in treating patients who have unresectable, locally advanced, or metastatic cancer of the esophagus or stomach.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastric Cancer||Drug: fluorouracil Drug: leucovorin calcium Drug: triacetyluridine||Phase 2|
- Assess the 6-month survival rate in patients with unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with triacetyluridine, fluorouracil, and leucovorin calcium.
- Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 30 minutes beginning 1 hour into leucovorin calcium infusion on days 1, 8, 15, 22, 29, and 36. Patients receive oral triacetyluridine every 8 hours on days 1-3, 8-10, 15-17, 22-24, 29-31, and 36-38 beginning 8 hours after completion of each fluorouracil infusion. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of PN-401, 5-FU and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2007|
Experimental: 5-FU, Leucovorin and PN-401
PN401 is given on Days 1-3 weekly for six weeks; 5FU and leucovorin are given on Day 1 weekely for six weeks; followed by two weeks of rest. Continued in 8 week cycles until one of the criteria for removal from treatment is met.
Other Name: 5-FUDrug: leucovorin calcium
Other Name: LCV; leucovorinDrug: triacetyluridine
Other Name: PN-401
- Six month survival [ Time Frame: six months after registration ]
- evaluate quantitative and qualitative toxicities [ Time Frame: three years at most ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004233
Show 97 Study Locations
|Study Chair:||James H. Doroshow, MD||City of Hope Comprehensive Cancer Center|