Tiger : A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

14+Age Over 14

Male Sexual<br/>System CancersCancer LocationMale Sexual
System Cancers

Systemic therapy | Urinary systemGerm cell tumour,Testis

Trial Overview Read MoreRead more

This phase III trial is comparing conventional-dose chemotherapy (TIP regimen) with high-dose chemotherapy plus an autologous stem cell transplant (TI-CE regimen) as initial salvage treatment for patients with germ cell tumours that have gotten worse or not responded to prior therapies.
 

This trial is treating patients with germ cell tumours.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

Cooperative Group

Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)

Summary

Patients enrolled in this trial will be randomised into one of two arms. In Arm A, patients will receive 4 cycles of TIP chemotherapy, administered every 21 days. Paclitaxel will be administered intravenously at a 250mg/m^2 dose on Day 1; Ifosfamide will be administered intravenously at a 1500mg/m^2 dose on Days 2-5; Cisplatin will be administered intravenously at a 25mg/m^2 dose on Days 2-5; and pedylated G-CSF 6mg will be administered subcutaneously on Day 6 or 7, or G-CSF as defined in the protocol on Days 6-18. In Arm B, patients will receive 5 cycles of the TI-CE treatment regimen. In cycles 1-2, patients will receive Paclitaxel 200mg/m^2 intravenously over 3 hours on Day 1; Ifosfamide 2000mg/m^2 intravenously on Days 1-3; G-CSF 10 ug/kg subcutaneously on Day 4 or Day 6 (cycle 1) and on Day 4 or Day 5 (cycle 2); and leukapheresis every 14 days. In cycles 3-5, patients will receive Carboplatin daily on Days 1-3; Etopside 400mg/m^2 daily on Days 1-3; stem cell reinfusion on Day 5; and pegylated G-CSF 6mg subcutaneously or G-CSF at appproximately 5ug/kg daily on Days 5-15.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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