Phase II clinical trial of 5-fluorouracil, trimetrexate, and leucovorin (NFL) in patients with advanced pancreatic cancer

  • Agustin A. Garcia
  • Lawrence Leichman
  • Joaquina Baranda
  • Lalita Pandit
  • Heinz-Josef Lenz
  • Cynthia G. Leichman
Research Article

Abstract

Background. Advanced pancreatic cancer has limited treatment options. 5-fluorouracil (5-FU) is frequently used in the treatment of pancreatic cancer. Preclinical studies suggest synergism between trimetrexate (TMTX), 5-FU, and leucovorin (NFL).

Aim. We conducted a phase II trial to evaluate the activity and safety of NFL in pancreatic cancer.

Method. Eligible patients (n=21) with untreated advanced pancreatic cancer were treated with 110 mg/m2 intravenous (IV) THTX on day 1 and 200 mg/m2 IV leucovorin prior to 500 mg/m2 IV 5-FU on day 2. Oral leucovorin (15 mg every 6 h for seven doses) started intravenous 24 h later.

Results. Treatment was administered for 6 wk followed by a 2-wk rest period. Response was evaluated every 8 wk. All patients were evaluable for response and toxicity. Most patients (80%) had distant metastases. Forty-five cycles of chemotherapy were administered. The most common serious toxicities were Grade 3 diarrhea (23.8%) and nausea and vomiting (14.2%). The response rate was 4.1% (95% CI, 0–23%), median survival was 6.8 mo, and 1-yr survival was 19%.

Conclusion. Treatment with NFL is well-tolerated in patients with advanced pancreatic cancer. The median survival and 1-yr survival in these patients with poor prognosis compares favorably with other treatment options.

Key Words

Pancreatic cancer chemotherapy 5-fluorouracil leucovorin trimetrexate 

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Copyright information

© Humana Press Inc 2003

Authors and Affiliations

  • Agustin A. Garcia
    • 1
  • Lawrence Leichman
    • 2
  • Joaquina Baranda
    • 3
  • Lalita Pandit
    • 4
  • Heinz-Josef Lenz
    • 1
  • Cynthia G. Leichman
    • 2
  1. 1.Norris Comprehensive Cancer CenterUniversity of Southern CaliforniaLos Angeles
  2. 2.Salick Health Care, Inc.Los Angeles
  3. 3.The Cancer Center of IrvineIrvine
  4. 4.Department of Veterans AffairsKansas City (VAMC)Kansas City

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