Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

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 got 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

Use the hyperlinks, where available to access additional clinical trial information.

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

Box Hill Hospital Medical Oncology
Box Hill
Lauren Mitchell
lauren.mitchell@monash.edu
03 9094 9544

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

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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