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S9915 Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00004233
First received: January 28, 2000
Last updated: July 21, 2011
Last verified: May 2010
History of Changes

January 28, 2000
July 21, 2011
February 2001
January 2007   (final data collection date for primary outcome measure)
Six month survival [ Time Frame: six months after registration ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00004233 on ClinicalTrials.gov Archive Site
evaluate quantitative and qualitative toxicities [ Time Frame: three years at most ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
S9915 Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach
A Phase II Study of PN-401, 5-FU and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach

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.

OBJECTIVES:

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • Drug: fluorouracil
    Other Name: 5-FU
  • Drug: leucovorin calcium
    Other Name: LCV; leucovorin
  • Drug: triacetyluridine
    Other Name: PN-401
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.
Interventions:
  • Drug: fluorouracil
  • Drug: leucovorin calcium
  • Drug: triacetyluridine
Doroshow JH, McCoy S, Macdonald JS, Issell BF, Patel T, Cobb PW, Yost KJ, Abbruzzese JL. Phase II trial of PN401, 5-FU, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach: a Southwest Oncology Group study. Invest New Drugs. 2006 Nov;24(6):537-42.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
January 2007
January 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction

  • No known brain metastases

    • Negative brain imaging required for neurologic signs and symptoms

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver tumor present)

Renal:

  • Creatinine no greater than ULN

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Must be able to swallow oral medication
  • No AIDS syndrome or HIV-associated complex
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy
  • No concurrent biologic therapy

Chemotherapy:

  • No prior chemotherapy for advanced or metastatic gastric cancer
  • At least 6 months since prior chemotherapy as adjuvant or radiation sensitizer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 1 month since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • At least 3 weeks since prior major surgical resection of intra-abdominal organs and recovered
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004233
CDR0000067477, CA32102, S9915
No
Laurence H. Baker, D.O.; Group Chair, Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: James H. Doroshow, MD Beckman Research Institute
Southwest Oncology Group
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP