A phase II trial of fixed-dosed rate gemcitabine in platinum-resistant ovarian cancer: a GEICO (Grupo Español de Investigación en Cáncer de Ovario) Trial.
OBJECTIVE
Gemcitabine has well-recognized activity in the treatment of ovarian cancer. Fixed-dose rate (FDR) delivery has been proposed as a more rationale way to administer gemcitabine, to avoid saturation of the enzyme that catalyzes its intracellular transformation into the active metabolites, difluorodeoxycitidine biphosphate, and triphosphate. Our aim was to assess clinical activity of gemcitabine delivered by FDR infusion in patients with platinum resistant ovarian cancer.


METHODS
Patients with platinum-resistant ovarian cancer received gemcitabine 1000 mg/m(2) over 120 minutes on days 1 and 8 of each cycle. Cycles were repeated every 3 weeks, and up to 6 cycles were delivered.


RESULTS
Forty-eight patients were included in the study. Among 41 patients evaluable for response, 9 clinical responses (1 complete response and 8 partial responses) were observed, achieving a global response rate of 22%. Grade 3 to 4 hematological toxicity consisted of anemia (15% of patients), neutropenia (24%), and thrombopenia (10%). One patient died due to septic shock. The main grade 3 to 4 nonhematological toxicity was asthenia (7 patients, 17%).


CONCLUSIONS
Activity of gemcitabine administered by FDR infusion in patients with platinum-resistant ovarian cancer seems similar to that achieved using 30-minute infusions, with higher toxicity.
Oncology Department, Hospital de la Santa Creu i Sant Pau, C/Padre Claret 167, Barcelona, Spain. mojeda@santpau.es
Belen
B
Ojeda Gonzalez
Antonio
A
Gonzalez Martin
Isabel
I
Bover Barcelo
Xavier
X
Fabregat i Mayol
Begoña
B
Mellado
María Jesus
MJ
Rubio Perez
Lorenzo
L
Alonso Carrion
Antonio
A
Casado Herraez
Elisa
E
Calvo Garcia
Cristina
C
Churruca Galaz
Angels
A
Arcusa Lanza
Ana
A
Herrero Ibañez
Encarna
E
Adrover Cebrian
Andres
A
Poveda Velasco
D018262:Adenocarcinoma, Clear Cell / Q000188:drug therapy / Q000556:secondary; D002288:Adenocarcinoma, Mucinous / Q000188:drug therapy / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D018269:Carcinoma, Endometrioid / Q000188:drug therapy / Q000556:secondary; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000009:adverse effects*; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D012264:Ribonucleotide Reductases / Q000037:antagonists & inhibitors; D015996:Survival Rate; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D009944:Organoplatinum Compounds; D003841:Deoxycytidine; D012264:Ribonucleotide Reductases; D000093542:Gemcitabine