Medical Oncology

, Volume 21, Issue 1, pp 59–66

Raltitrexed plus weekly oxaliplatin as first-line chemotherapy in metastatic colorectal cancer

A multicenter non-randomized phase II study
  • Daniele Santini
  • Cristian Massacesi
  • Rolando Maria D’Angelillo
  • Fabiana Marcucci
  • Costantino Campisi
  • Bruno Vincenzi
  • Alberta Pilone
  • Vincenzo Bianco
  • Maurizio Bonsignori
  • Giuseppe Tonini
Original Article

DOI: 10.1385/MO:21:1:59

Cite this article as:
Santini, D., Massacesi, C., D’Angelillo, R.M. et al. Med Oncol (2004) 21: 59. doi:10.1385/MO:21:1:59

Abstract

Aim: The primary aims of this study were activity and toxicity evaluation of a new raltitrexed and oxaliplatin-based regimen, as a first-line chemotherapy, in patients with metastatic colorectal cancer (MCC). Survival evaluation was considered a secondary endpoint.

Patients and Methods: Forty-four patients were enrolled into this phase II trial. Treatment consisted of raltitrexed 3 mg/m2 iv on d 1 and oxaliplatin 70 mg/m2 iv on d 1 and d 8 every 3 wk.

Results: Twenty patients (45.5%) achieved a response [95% confidence interval (CI): 30.1% to 54.1%], 18 (40.9%) had stable disease, and only 6 (13.6%) developed progressive disease. After a median follow-up time of 14.7 mo (range 6.3–18.6 mo), the median time to disease progression was 6 mo (range 2.0–16.7) (95% CI: 4.4–7.6) and the overall survival was 14.8 mo (range 3–23) (95% CI: 11.2–18.4). Neutropenia was the most common hematological side effect, while transient AST/ALT increase, neurotoxicity, asthenia, and diarrhea were the most common nonhematological side effects.

Conclusions: Our data confirmed that oxaliplatin administered weekly plus raltitrexed is an active combination in newly diagnosed patients with advanced colorectal carcinoma that merits further investigation versus the classic schedule in a randomized, phase III trial.

Key Words

Advanced colorectal cancerfirst-line chemotherapyphase II trialraltitrexedoxaliplatin

Copyright information

© Humana Press Inc 2004

Authors and Affiliations

  • Daniele Santini
    • 1
  • Cristian Massacesi
    • 2
  • Rolando Maria D’Angelillo
    • 1
  • Fabiana Marcucci
    • 2
  • Costantino Campisi
    • 3
  • Bruno Vincenzi
    • 1
  • Alberta Pilone
    • 2
  • Vincenzo Bianco
    • 4
  • Maurizio Bonsignori
    • 2
  • Giuseppe Tonini
    • 1
  1. 1.Medical OncologyUniversity Campus Bio-MedicoRomeItaly
  2. 2.Department of Oncology and RadiotherapyAzienda Ospedaliera Umberto IAncona
  3. 3.National Council of Research (CNR)Rome
  4. 4.Medical OncologyOspedale Civile di ColleferroRome