A phase II multicenter study of oxaliplatin in combination with paclitaxel in poor prognosis patients who failed cisplatin-based chemotherapy for germ-cell tumors.
BACKGROUND
The aim of this study is to determine feasibility and efficacy of the combination regimen oxaliplatin and paclitaxel in patients with cisplatin (CDDP)-refractory germ-cell tumors (GCT).


METHODS
Patients with either a cisplatin absolute-refractory GCT defined as progressive disease (PD) during or within 1 month of CDDP administration or with a poor prognosis relapse, defined as PD between the second and the sixth month after CDDP administration, were treated with a combination of oxaliplatin (130 mg/m(2)) and paclitaxel (175 mg/m(2)) administered every 21 days. Primary end point was efficacy.


RESULTS
Twenty-seven patients were included. Patients were pretreated with a median of two lines of cisplatin-based chemotherapy (range 1-5). Sixteen patients were absolute refractory. Five patients had relapsed after high-dose chemotherapy plus stem-cell support. There were no complete responses but there was one marker-positive partial response and nine disease stabilization (34, 6%). After a median follow-up of 65 months, two patients are disease-free survivors. Main toxicity was leucocytopenia grade 3/4 in 30% of the patients.


CONCLUSIONS
Combination chemotherapy with oxaliplatin and paclitaxel is feasible with acceptable toxicity and may be effective if combined with additional treatment in patients with CDDP-refractory GCT.
Theodore
C
C
Department of Medicine, Institut Gustave Roussy, Villejuif. Electronic address: c.theodore@hopital-foch.org.
Chevreau
C
C
Department of Medicine, Institut Claudius Regaud, Toulouse.
Yataqhene
Y
Y
Department of Oncology, Sanofi aventis pharmaceuticals Paris.
Fizazi
K
K
Department of Medicine, Institut Gustave Roussy, Villejuif.
Delord
J-P
JP
Department of Medicine, Institut Claudius Regaud, Toulouse.
Lotz
J-P
JP
Department of Medicine, Hopital Tenon, Paris.
Geoffrois
L
L
Department of Oncology, Centre Alexis Vautrin, Nancy.
Kerbrat
P
P
Department of Medicine, Centre Eugène. Marquis, Rennes.
Bui
V
V
Department of Medicine, Institut Bergoniè, Bordeaux.
Flechon
A
A
Department of Medicine, Centre. Léon Bérard, Lyon, France.
D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D000077150:Oxaliplatin; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D013736:Testicular Neoplasms / Q000188:drug therapy*
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D017239:Paclitaxel