Phoenix, Arizona 85012

  • Gastric Cancer

Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

CDR0000067477


NCT ID:

NCT00004233


Secondary ID:

CA32102


Study Acronym:


Brief Title:

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


Official Title:

A Phase II Study of PN-401, 5-FU and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southwest Oncology Group


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

65


Enrollment Type:

Actual


Overall Contact Information

Official Name:James H. Doroshow, MD
Study Chair
Beckman Research Institute

Study Dates

Start Date:February 2001
Completion Date:January 2007
Completion Type:Actual
Primary Completion Date:January 2007
Primary Completion Type:Actual
Verification Date:May 2010
Last Changed Date:July 21, 2011
First Received Date:January 28, 2000

Study Outcomes

Outcome Type:Primary Outcome
Measure:Six month survival
Time Frame:six months after registration
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:evaluate quantitative and qualitative toxicities
Time Frame:three years at most
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:fluorouracil
Arm Name:5-FU, Leucovorin and PN-401
Other Name:5-FU
Intervention Type:Drug
Name:leucovorin calcium
Arm Name:5-FU, Leucovorin and PN-401
Other Name:LCV; leucovorin
Intervention Type:Drug
Name:triacetyluridine
Arm Name:5-FU, Leucovorin and PN-401
Other Name:PN-401

Study Arms

Study Arm Type:Experimental
Arm Name:5-FU, Leucovorin and PN-401
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:16832602

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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