title: Phase II study of paclitaxel in patients with relapsed or cisplatin-refractory testicular cancer.
abstract: BACKGROUND
  Despite generally high cure rates in patients with metastatic testicular cancer, patients with incomplete responses to cisplatin-based first-line therapy or with relapsed disease have an extremely poor prognosis. Paclitaxel represents an antitumor agent with demonstrated activity in cisplatin-sensitive tumors. In addition, responses to paclitaxel have been observed in patients with platin-refractory ovarian cancers. The current phase II trial evaluates the role of paclitaxel in male patients with cisplatin-refractory or relapsed malignant germ cell tumors.
  
  
  METHODS
  Twenty-four patients with relapsed, mostly cisplatin-refractory metastatic testicular cancer were treated with paclitaxel as three-hour infusions of 225 mg/m2 at 3-weekly intervals. The patients had received a median of 7 platinum-containing treatment cycles (range 3-12) prior to paclitaxel and 12 patients (50%) had previously received high-dose carboplatin/etoposide-based salvage therapy with autologous stem cell support.
  
  
  RESULTS
  Six patients (25%) achieved major responses to paclitaxel with 2 CR (8%) and 4 PR with marker normalisation (17%). In addition, 5 patients (21%) showed disease stabilisation. Median duration of responses to paclitaxel was 8 months (3-16+). Toxicity was tolerable, with mainly granulocytopenia occurring in 50% of patients and peripheral neuropathy > or = grade II in 29%.
  
  
  CONCLUSIONS
  Paclitaxel demonstrates significant antitumor activity in 25% of patients with relapsed or cisplatin-refractory testicular cancer. Combination regimens including paclitaxel may be warranted.
authors.affiliation: Eberhard Karls University, Department of Internal Medicine II, Hematology/Oncology, Tubingen, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Bokemeyer
authors.forename: J
authors.initials: J
authors.lastname: Beyer
authors.forename: B
authors.initials: B
authors.lastname: Metzner
authors.forename: U
authors.initials: U
authors.lastname: Ruther
authors.forename: A
authors.initials: A
authors.lastname: Harstrick
authors.forename: L
authors.initials: L
authors.lastname: Weissbach
authors.forename: U
authors.initials: U
authors.lastname: Kohrmann
authors.forename: W
authors.initials: W
authors.lastname: Verbeek
authors.forename: H J
authors.initials: HJ
authors.lastname: Schmoll
mesh_terms: D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D018237:Germinoma / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D013736:Testicular Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel; D002945:Cisplatin