A phase i study of the oral platinum agent satraplatin in combination with oral vinorelbine in patients with advanced solid malignancies

Elisa Gallerani, Richard Cathomas, Cristiana Sessa, Tiziana Digena, Anna Amalia Bartosek, Laura Dal Zotto, Roger Von Moos

Research output: Contribution to journalArticle

Abstract

Background: The broad spectrum of antitumor activity of the oral platinum satraplatin (S) and vinorelbine (V) were the rationale for performing a phase I trial to define the maximum tolerated (MTD) and the recommended (RD) dose in adult patients with advanced solid tumors. Patients and Methods: 4 dose levels (DLs) of S (mg/m2/day, days 1-5) and V (mg/m2/day, days 1, 8, 15, and 22) every 28 days were explored: S60/V60 on days 1, 8 and 15 only; S60/V60; S70/V60; and S80/V60. Subsequently, 3 further DLs were evaluated with V omitted on day 22: S70/V60, S80/V60, and S80/V80. Results: Treating 27 patients, the MTD was S80/V80 on days 1, 8, and 15, with 2 dose-limiting toxicities in 2 patients (nausea and vomiting grade (G) 3 with skipping of V on day 15, and neutropenia G4 with infection). The RD was S80/V60 on days 1, 8, and 15. The most frequent toxicities (any G) were nausea (70%), diarrhea (59%), anorexia (37%), vomiting (33%), asthenia (26%), constipation (26%), and paresthesia (18%). Partial responses were observed in 2 platinum-sensitive ovarian cancer patients and in 1 prostate cancer patient. Conclusion: The combination of S and V is tolerable at a DL of S80/V60 on days 1, 8, and 15; further evaluations in platinum-and V-sensitive tumor types would be of interest.

Original languageEnglish
Pages (from-to)40-45
Number of pages6
JournalOnkologie
Volume36
Issue number1-2
DOIs
Publication statusPublished - Feb 2013

Fingerprint

Platinum
Neoplasms
Nausea
Vomiting
Asthenia
Maximum Tolerated Dose
Paresthesia
Anorexia
Constipation
Neutropenia
Ovarian Neoplasms
satraplatin
vinorelbine
Diarrhea
Prostatic Neoplasms
Infection

Keywords

  • Oral navelbine
  • Satraplatin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Hematology

Cite this

Gallerani, E., Cathomas, R., Sessa, C., Digena, T., Bartosek, A. A., Zotto, L. D., & Von Moos, R. (2013). A phase i study of the oral platinum agent satraplatin in combination with oral vinorelbine in patients with advanced solid malignancies. Onkologie, 36(1-2), 40-45. https://doi.org/10.1159/000346671

A phase i study of the oral platinum agent satraplatin in combination with oral vinorelbine in patients with advanced solid malignancies. / Gallerani, Elisa; Cathomas, Richard; Sessa, Cristiana; Digena, Tiziana; Bartosek, Anna Amalia; Zotto, Laura Dal; Von Moos, Roger.

In: Onkologie, Vol. 36, No. 1-2, 02.2013, p. 40-45.

Research output: Contribution to journalArticle

Gallerani, E, Cathomas, R, Sessa, C, Digena, T, Bartosek, AA, Zotto, LD & Von Moos, R 2013, 'A phase i study of the oral platinum agent satraplatin in combination with oral vinorelbine in patients with advanced solid malignancies', Onkologie, vol. 36, no. 1-2, pp. 40-45. https://doi.org/10.1159/000346671
Gallerani, Elisa ; Cathomas, Richard ; Sessa, Cristiana ; Digena, Tiziana ; Bartosek, Anna Amalia ; Zotto, Laura Dal ; Von Moos, Roger. / A phase i study of the oral platinum agent satraplatin in combination with oral vinorelbine in patients with advanced solid malignancies. In: Onkologie. 2013 ; Vol. 36, No. 1-2. pp. 40-45.
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