Phase II clinical trial of oxaliplatin and bevacizumab in refractory germ cell tumors

Amit Jain, Mary J. Brames, David J. Vaughn, Lawrence Einhorn

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

BACKGROUND: Salvage chemotherapy has curative potential in germ cell tumors (GCTs). However, novel therapies are still needed for patients failing to be cured with standard salvage chemotherapy. Bevacizumab in combination with chemotherapy has clinical activity in many solid tumors. This is the first study of bevacizumab with oxaliplatin in refractory GCT patients.

PATIENTS AND METHODS: Patients with metastatic GCT with progressive disease after second-line or later salvage chemotherapy were eligible. Prior high-dose chemotherapy and paclitaxel and/or gemcitabine were required unless primary mediastinal nonseminomatous GCT or late relapse. Patients received oxaliplatin-85 mg/m and bevacizumab-10 mg/kg every 2 weeks for a maximum of 14 cycles.

RESULTS: Twenty-nine patients were enrolled and evaluated. Nine patients were late relapses and 5 had primary mediastinal nonseminomatous GCT. Median number of prior chemotherapy regimens was 4. There was no grade 4 and only 1 grade 3 toxicity. Although the primary endpoint of 12 months disease-free survival was not achieved, 8 patients (27.6%) had objective response including 1 complete remission. Median duration of remission was 5 months (range, 4 to 22 mo).

CONCLUSIONS: Oxaliplatin plus bevacizumab was well tolerated in heavily pretreated GCTs with manageable adverse events. There was modest clinical activity but only 1 patient achieved complete remission.

Original languageEnglish (US)
Pages (from-to)450-453
Number of pages4
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume37
Issue number5
DOIs
StatePublished - Oct 1 2014

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oxaliplatin
Phase II Clinical Trials
Germ Cell and Embryonal Neoplasms
Drug Therapy
gemcitabine
Recurrence
Bevacizumab
Paclitaxel
Combination Drug Therapy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Phase II clinical trial of oxaliplatin and bevacizumab in refractory germ cell tumors. / Jain, Amit; Brames, Mary J.; Vaughn, David J.; Einhorn, Lawrence.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 37, No. 5, 01.10.2014, p. 450-453.

Research output: Contribution to journalArticle

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