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Ifex (Ifosfamide) - Summary



Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death. Monitor for CNS toxicity and discontinue treatment for encephalopathy. Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna. [see Warnings and Precautions (5.1-5.3)]



IFEX (ifosfamide for injection, USP) single-dose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide.

IFEX is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.

See all Ifex indications & dosage >>


Media Articles Related to Ifex (Ifosfamide)

Creatine Linked to Testicular Cancer
Source: MedicineNet Testicular Cancer Specialty [2015.04.17]
Title: Creatine Linked to Testicular Cancer
Category: Health News
Created: 4/17/2015 12:00:00 AM
Last Editorial Review: 4/17/2015 12:00:00 AM

10 Testicular Cancer Symptoms and Signs
Source: MedicineNet Testicular Cancer Specialty [2015.04.03]
Title: 10 Testicular Cancer Symptoms and Signs
Category: Doctor's & Expert's views on Symptoms
Created: 2/19/2003 12:00:00 AM
Last Editorial Review: 4/3/2015 12:00:00 AM

Testicular Cancer May Raise Prostate Cancer Risk: Study
Source: MedicineNet Testicular Cancer Specialty [2015.02.24]
Title: Testicular Cancer May Raise Prostate Cancer Risk: Study
Category: Health News
Created: 2/23/2015 12:00:00 AM
Last Editorial Review: 2/24/2015 12:00:00 AM

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Published Studies Related to Ifex (Ifosfamide)

A randomized phase III study comparing standard dose BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support in males with poor-prognosis germ-cell cancer. An intergroup study of EORTC, GTCSG, and Grupo Germinal (EORTC 30974). [2011.05]
CONCLUSION: This study could not demonstrate that high-dose chemotherapy given as part of first-line therapy improves outcome in patients with poor-prognosis GCC.

Phase III trial of standard versus dose-intensified doxorubicin, ifosfamide and dacarbazine (MAID) in the first-line treatment of metastatic and locally advanced soft tissue sarcoma. [2009.10]
Multidrug chemotherapy increases responses in advanced soft tissues sarcoma. Can a 20% increase of relative dose intensity of the MAID regimen, more improve responses? From 1994 to 1997, 162 patients were randomized in a phase III study to the conventional drug combination (6 cycles of MAID: 60, 7,500, 900 mg/m(2) for doxorubicin, ifosfamide and dacarbazine respectively), or at doses 20-33% higher per cycle (5 cycles of intensified MAID for similar cumulative doses) with systematic G-CSF...

Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. [2009.09.01]
PURPOSE: To evaluate the safety and efficacy of trabectedin in a phase II, open-label, multicenter, randomized study in adult patients with unresectable/metastatic liposarcoma or leiomyosarcoma after failure of prior conventional chemotherapy including anthracyclines and ifosfamide... CONCLUSION: Prior studies showed clinical benefit with trabectedin in patients with sarcomas after failure of standard chemotherapy. This trial documents superior disease control with the q3 weeks 24-hour trabectedin regimen in liposarcomas and leiomyosarcomas, although the qwk 3-hour regimen also demonstrated activity relative to historical comparisons. Trabectedin may now be considered an important new option to control advanced sarcomas in patients after failure of available standard-of-care therapies.

Randomized multicenter phase II trial of cisplatin and ifosfamide with or without paclitaxel in recurrent or metastatic carcinoma of the uterine cervix: a Hellenic Cooperative Oncology Group (HeCOG) study. [2009.08]
BACKGROUND: We undertook a randomized phase II trial to test whether the addition of paclitaxel (Taxol) to the cisplatin and ifosfamide (IP) combination could improve objective response (OR) rate, progression-free survival (PFS) and overall survival (OS) in patients with recurrent or metastatic cancer of the uterine cervix... CONCLUSION: The ITP combination merits further investigation in randomized phase III studies.

Chemotherapy: The role of ifosfamide and etoposide in Ewing sarcoma. [2009.05]
The EICESS-92 Trial compared the efficacy of cyclophosphamide and ifosfamide in patients with Ewing sarcoma. Subgroup analysis suggested that patients with large, localized tumors benefited from the addition of etoposide, whereas patients with metastases did not..

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Clinical Trials Related to Ifex (Ifosfamide)

Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors [Recruiting]
This is an open-label study of palifosfamide-tris administered intravenously on Days 1, 2, and 3 of a 21-day cycle to subjects with advanced solid tumors. Enrolled subjects will

receive a placebo-control infusion on Day - 1 and then commence palifosfamide-tris study

treatment 24 hours later on Day 1.

Time-matched, intensive ECG monitoring will occur during and following placebo and

palifosfamide-tris infusions on Days - 1, 1, 2, 3 and 8. Generation of ECG data for study

analysis will be performed in a blinded fashion at a central ECG laboratory.

Blood and urine sampling to characterize the pharmacokinetics of palifosfamide-tris will be performed on Days 1 through 8 of Cycle 1.

Fosaprepitant in Patients Receiving Ifosfamide-based Regimen [Recruiting]
The goal of this clinical research study is to learn how different doses of fosaprepitant may effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may be caused by chemotherapy. The safety of this drug will also be studied.

Fosaprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by chemotherapy.

Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. An autologous peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ifosfamide when given together with paclitaxel and carboplatin followed by an autologous stem cell transplant and to see how well they work in treating patients with germ cell tumors that did not respond to cisplatin.

Neoadyuvant High-dose of Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma [Recruiting]
To study the activity and toxicity of a neoadjuvant regimen including high-dose ifosfamide in combination with radiotherapy, and subsequent surgery, in high-risk soft tissue sarcomas.

Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma [Recruiting]
The combination of a platinating agent with etoposide has been used for a variety of pediatric tumors, including medulloblastomas, intracranial PNETs, neuroblastomas, Wilms tumors, germ cell tumors, lymphomas and retinoblastomas. Oxaliplatin, trans-l-1,2-diaminocyclohexane (DACH) oxalatoplatinum, is a novel platinum agent that, in preclinical models, has as much efficacy as cisplatin and is active against cells that are resistant to cisplatin. In clinical trials, oxaliplatin has little ototoxicity, nephrotoxicity, or myelosuppression. Therefore, oxaliplatin may be useful in patients who have tumors that are refractory to cisplatin. Additionally, the combination of oxaliplatin and etoposide may be as potent as the combination of cisplatin or carboplatin with etoposide with less toxicity.

This study will define the Maximum Tolerated Dose of the combination of oxaliplatin and etoposide as well as describe the toxicities associated with the combination. Oxaliplatin will be administered initially at the recommended pediatric phase II dose of 130 mg/m2 intravenously over 2 hours every 3 weeks. Etoposide will be administered at a starting dose of 75 mg/m2 over 1 hour intravenously immediately after the infusion of oxaliplatin on day 1 and then on days 2 and 3 every 3 weeks.

Dose-limiting toxicity (DLT) is defined as any first course grade 3 or 4 non-hematologic toxicity (with the specific exclusion of grade 3 nausea and vomiting, grade 3 fever or infection, grade 3 electrolyte abnormalities, or grade 3 hepatotoxicity which returns to a grade 1 prior to the next treatment course).

Once a tolerable regimen of oxaliplatin and etoposide was defined, the study was amended to add ifosfamide to the regimen. This 3-drug regimen would be similar to the commonly used regimen of ifosfamide, carboplatin, and etoposide (ICE).This combination will investigate whether this combination produce similar responses, possibly with less toxicity. If any of the dose-limiting toxicity at any of these levels is prolonged neutropenia, then filgrastim (or pegfilgrastim) support will be added.

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Page last updated: 2015-04-17

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