Clinical Trial: Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Dose Intensification Phase II Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis. TICE Protocol : Paclitaxel and Ifosfamide Followed by Carboplatine and E

Brief Summary:

Not randomized, multicentric, national phase II trial estimating the efficacy of an intensification protocol in patients with refractory germ cell tumors with relapse and bad prognosis.

Treatment consists in two Paclitaxel and Ifosfamide intensification cycles followed by three Carboplatine and Etoposide high dose cycles. The point is the individual Carboplatine adjustment to take into account inter-individual patients variability.

This adaptation allow to control each patient plasmatic exposition to avoid both inacceptable toxicities (such as ear toxicity) and a low exposition losing then the benefit of this high dose protocol.


Detailed Summary:
Sponsor: Institut Claudius Regaud

Current Primary Outcome: Complete response rate(by chemotherapy or chemotherapy + surgery), pathological complete response rate. [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression free survival [ Time Frame: 8 years ]
  • Time to progression [ Time Frame: 8 years ]
  • Toxicity [ Time Frame: 6 months ]
  • To find a predictive value for Cystatin C as a biomarker of renal function to avoid next to follow plasmatic concentrations to adapt Carboplatine dose in TICE protocol. [ Time Frame: 4 years ]
  • Etoposide pharmacokinetics (in particular inter-individual variability of Etoposide plasmatic concentrations AUC in such patients [ Time Frame: 4 years ]
  • Genetic polymorphisms involved in response and safety treatments [ Time Frame: 4 years ]


Original Secondary Outcome: Same as current

Information By: Institut Claudius Regaud

Dates:
Date Received: March 16, 2009
Date Started: March 2009
Date Completion: September 2029
Last Updated: March 26, 2015
Last Verified: March 2015