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Home > GU GCT Metastatic - TI [PACLItaxel and IFOSFamide] [Part ONE of TICE]

GU GCT Metastatic - TI [PACLItaxel and IFOSFamide] [Part ONE of TICE]

Treatment Overview

This regimen is Part ONE of TICE.

For Part TWO, see HSCT Autologous conditioning - CE [cARBOplatin and etoposide] [Part TWO of TICE for Metastatic germ cell tumour]


TICE consists of TWO parts (see also Additional details for Treatment Schema):

  • Part ONE: 2 cycles of TI [PACLItaxel and IFOSFamide] (below), followed by
  • Part TWO: 3 cycles of CE [cARBOplatin and etoposide] conditioning with autologous stem cell transplant.

This regimen contains a medicine where one or more biosimilars may exist. Any biosimilars used have been reviewed by the regulator (Medsafe) and relevant specialists were consulted nationally. Where regulators, in consultation with relevant specialists, have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably.

Cycles 1 to 2 - 14 days

Cycle length:
14

PACLItaxel: Some centres may choose to administer PACLItaxel IV infusion over 3 hours.


filgrastim:

  • Give 5 microgram/kg subcutaneously TWICE daily from Day 5 until stem cell harvest complete.
  • If sufficient mobilisation in Cycle 1, use standard supportive care filgrastim post Cycle 2.

Cycle details

Cycles 1 to 2 - 14 days

Medication Dose Route Days Max Duration
dexamethasone * 20 mg oral administration 0
dexamethasone * 12 mg oral administration 1
loratadine * 10 mg oral administration 1
famotidine * 20 mg oral administration 1
PACLItaxel * 200 mg/m² intravenous 1 24 hours Min: 24 hours
olanzapine * 5 mg oral administration 2 to 7
aprepitant 125 mg oral administration 2
aprepitant 80 mg oral administration 3, 4
dexamethasone * 8 mg oral administration 2 to 7
ondansetron 8 mg oral administration 2, 3, 4
sodium chloride 0.9 % intravenous 2, 3, 4 120 minutes
mesna 400 mg/m² intravenous 2, 3, 4 15 minutes
IFOSFamide * 2000 mg/m² Once daily intravenous 2, 3, 4 4 hours
mesna 1200 mg/m² Once daily intravenous 2, 3, 4 4 hours
sodium chloride 0.9 % intravenous 2, 3, 4 120 minutes
mesna 400 mg/m² intravenous 2, 3, 4 15 minutes
mesna 400 mg/m² intravenous 2, 3, 4 15 minutes
ondansetron 8 mg oral administration 2, 3, 4
filgrastim 5 microgram/kg Twice daily subcutaneous injection 5
cyclIZINE 50 mg Three times daily oral administration 1
docusate sodium + sennoside B 2 Tablet(s) oral administration 1

PACLItaxel: Some centres may choose to administer PACLItaxel IV infusion over 3 hours.


filgrastim:

  • Give 5 microgram/kg subcutaneously TWICE daily from Day 5 until stem cell harvest complete.
  • If sufficient mobilisation in Cycle 1, use standard supportive care filgrastim post Cycle 2.

Full details

Cycles 1 to 2 - 14 days

Day: 0

Medication Dose Route Max duration Details
dexamethasone * 20 mg oral administration
Instructions:

Take the night prior to PACLItaxel infusion with food.

  • If the initial infusion(s) of PACLItaxel are well tolerated, clinicians may decide at their discretion, to omit this dose.

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 12 mg oral administration
Instructions:

ONE hour prior to PACLItaxel with food.
loratadine * 10 mg oral administration
Instructions:

ONE hour prior to PACLItaxel.
famotidine * 20 mg oral administration
Instructions:

ONE hour prior to PACLItaxel infusion.

  • Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
PACLItaxel * 200 mg/m² intravenous 24 hours Min: 24 hours
Instructions:

Continuous infusion over 24 hours.

  • Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size.
  • Please carry out graded challenge as per institutional policy.
cyclIZINE 50 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

  • Warning: may cause drowsiness.
  • Consider starting dose at 25 mg and increasing as tolerated/required.
  • The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.
  • Note that domperidone is not recommended in combination with olanzapine and ondansetron due to potential risk of QT prolongation.
docusate sodium + sennoside B 2 Tablet(s) oral administration
Instructions:

At night when required for constipation.

Each tablet contains docusate sodium 50 mg + sennoside B 8 mg.

Day: 2

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
  • Some centres may choose to omit pre-chemotherapy dose or advise patient to take the night before chemotherapy if patient has to drive to appointment.
aprepitant 125 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy with food.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
sodium chloride 0.9 % intravenous 120 minutes
Quantity:1000 mL
Instructions:

Prior to IFOSFamide infusion.

  • Recommended daily hydration is 3000 ml per day as oral or IV fluid on day(s) of IFOSFamide and for 24 hours after, or as per institutional practice.
mesna 400 mg/m² intravenous 15 minutes
Instructions:

Immediately prior to IFOSFamide infusion over 15 minutes, or as per institutional practice 
IFOSFamide * 2000 mg/m² Once daily intravenous 4 hours
Instructions:

Admixed with mesna 1200 mg/m2.
mesna 1200 mg/m² Once daily intravenous 4 hours
Instructions:

Admixed with IFOSFamide, or give as per institutional practice.
sodium chloride 0.9 % intravenous 120 minutes
Quantity:1000 mL
Instructions:

After IFOSFamide infusion.

  • Recommended daily hydration is 3000 ml per day as oral or IV fluid on day(s) of IFOSFamide and for 24 hours after, or as per institutional practice.
mesna 400 mg/m² intravenous 15 minutes
Instructions:

At 8 hours from start of IFOSFamide infusion or as per institutional practice.
mesna 400 mg/m² intravenous 15 minutes
Instructions:

At 12 hours from start of IFOSFamide infusion or as per institutional practice.
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 3

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
sodium chloride 0.9 % intravenous 120 minutes
Quantity:1000 mL
Instructions:

Prior to IFOSFamide infusion.

  • Recommended daily hydration is 3000 ml per day as oral or IV fluid on day(s) of IFOSFamide and for 24 hours after, or as per institutional practice.
mesna 400 mg/m² intravenous 15 minutes
Instructions:

Immediately prior to IFOSFamide infusion over 15 minutes, or as per institutional practice 
IFOSFamide * 2000 mg/m² Once daily intravenous 4 hours
Instructions:

Admixed with mesna 1200 mg/m2.
mesna 1200 mg/m² Once daily intravenous 4 hours
Instructions:

Admixed with IFOSFamide, or give as per institutional practice.
sodium chloride 0.9 % intravenous 120 minutes
Quantity:1000 mL
Instructions:

After IFOSFamide infusion.

  • Recommended daily hydration is 3000 ml per day as oral or IV fluid on day(s) of IFOSFamide and for 24 hours after, or as per institutional practice.
mesna 400 mg/m² intravenous 15 minutes
Instructions:

At 8 hours from start of IFOSFamide infusion or as per institutional practice.
mesna 400 mg/m² intravenous 15 minutes
Instructions:

At 12 hours from start of IFOSFamide infusion or as per institutional practice.
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 4

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
sodium chloride 0.9 % intravenous 120 minutes
Quantity:1000 mL
Instructions:

Prior to IFOSFamide infusion.

  • Recommended daily hydration is 3000 ml per day as oral or IV fluid on day(s) of IFOSFamide and for 24 hours after, or as per institutional practice.
mesna 400 mg/m² intravenous 15 minutes
Instructions:

Immediately prior to IFOSFamide infusion over 15 minutes, or as per institutional practice 
IFOSFamide * 2000 mg/m² Once daily intravenous 4 hours
Instructions:

Admixed with mesna 1200 mg/m2.
mesna 1200 mg/m² Once daily intravenous 4 hours
Instructions:

Admixed with IFOSFamide, or give as per institutional practice.
sodium chloride 0.9 % intravenous 120 minutes
Quantity:1000 mL
Instructions:

After IFOSFamide infusion.

  • Recommended daily hydration is 3000 ml per day as oral or IV fluid on day(s) of IFOSFamide and for 24 hours after, or as per institutional practice.
mesna 400 mg/m² intravenous 15 minutes
Instructions:

At 8 hours from start of IFOSFamide infusion or as per institutional practice.
mesna 400 mg/m² intravenous 15 minutes
Instructions:

At 12 hours from start of IFOSFamide infusion or as per institutional practice.
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 5

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • Dose and duration may be individualised at clinician’s discretion.
filgrastim 5 microgram/kg Twice daily subcutaneous injection
Instructions:

Give TWICE daily from Day 5 until stem cell harvest complete.

  • If sufficient mobilisation in Cycle 1, use standard supportive care filgrastim post Cycle 2.
  • Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 6

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • Dose and duration may be individualised at clinician’s discretion.

Day: 7

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
  • Some centres may choose to omit pre-chemotherapy dose or advise patient to take the night before chemotherapy if patient has to drive to appointment.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • Dose and duration may be individualised at clinician’s discretion.

Additional details

Section 1: Treatment Schema

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Routine antifungal prophylaxis recommended
Antiviral prophylaxis for hepatitis B virus: Required for anti–HBc positive patients at risk of reactivation
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Constipation risk: laxatives are usually prescribed
Emetogenicity: Variable
Growth factor support: Recommended for primary prophylaxis
Hydration: Routine hydration recommended
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Irradiated blood components: Irradiation of blood components is recommended
Mesna uroprotection: Routine mesna uroprotection recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis may be considered

Emetogenicity: LOW day 1, HIGH days 2, 3 and 4.

References

Wood L, Kollmannsberger C, Jewett M et al. 2010 "Canadian consensus guidelines for the management of testicular germ cell cancer". Can Urol Assoc J. 2010 Apr;4(2):e19-38., PMID: 20368885

Einhorn LH, Williams SD, Chamness A et al. 2007 " High-dose chemotherapy and stem-cell rescue for metastatic germ-cell tumors". N Engl J Med. Jul 26;357(4):340-8., PMID: 17652649

Agarwal R, Dvorak CC, Stockerl-Goldstein KE et al. 2009. High-dose chemotherapy followed by stem cell rescue for high-risk germ cell tumors: the Stanford experience. Bone Marrow Transplant. 2009 Apr;43(7):547-52., PMID: 18997833

Lorch A, Bascoul-Mollevi C, Kramar A et al. 2011 Conventional-dose versus high-dose chemotherapy as first salvage treatment in male patients with metastatic germ cell tumors: evidence from a large international database. J Clin Oncol. Jun 1;29(16):2178-84., PMID: 21444870

Pico JL, Rosti G, Kramar A et al. 2005 A randomised trial of high-dose chemotherapy in the salvage treatment of patients failing first-line platinum chemotherapy for advanced germ cell tumours.Ann Oncol. 2005 Jul;16(7):1152-9., PMID: 15928070

Beyer, J., S. Stenning, A. Gerl, et al. 2002. "High-dose versus conventional-dose chemotherapy as first-salvage treatment in patients with non-seminomatous germ-cell tumors: a matched-pair analysis." Ann Oncol 13(4):599-605., PMID: 12056711

Lorch A, Kollmannsberger C, Hartmann JT et al. 2007 " Single versus sequential high-dose chemotherapy in patients with relapsed or refractory germ cell tumors: a prospective randomized multicenter trial of the German Testicular Cancer Study Group ". J Clin Oncol. Jul 1;25(19):2778-84., PMID: 17602082

Kondagunta GV, Bacik J, Sheinfeld J et al. 2007 "Paclitaxel plus Ifosfamide followed by high-dose carboplatin plus etoposide in previously treated germ cell tumors". J Clin Oncol. Jan 1;25(1):85-90., PMID: 17194908

Feldman, D. R., J. Sheinfeld, D. F. Bajorin, et al. 2010. "TI-CE high-dose chemotherapy for patients with previously treated germ cell tumors: results and prognostic factor analysis." J Clin Oncol 28(10):1706-1713., PMID: 20194867

Bubalo J, Carpenter PA, et al; American Society for Blood and Marrow Transplantation practice guideline committee. Conditioning chemotherapy dose adjustment in obese patients: a review and position statement by the American Society for Blood and Marrow Transplantation practice guideline committee. Biol Blood Marrow Transplant. 2014 May;20(5):600-16. doi: 10.1016/j.bbmt.2014.01.019. Epub 2014 Jan 23., PMID: 24462742

New Zealand Blood Service Transfusion Medicine Handbook Third Edition, 2016.

Boulanger J, Boursiquot JN, Cournoyer G, et al. Management of hypersensitivity to platinum- and taxane-based chemotherapy: cepo review and clinical recommendations. Curr Oncol. 2014;21(4):e630-e641., PMID: 25089112

Castells, M.C., Matulonis, U.A., and Horton, TM. Infusion reactions to systemic chemotherapy. Savarese DMF and Feldweg AM, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com/contents/infusion-reactions-to-systemic-chemotherapy (Accessed 26 March 2021).

Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142., PMID: 28848668

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14., PMID: 29443651

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.