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Phase II Study of Ifosfamide, Carboplatin, and Etoposide (ICE) with Amifostine Chemoprotection in Patients with Metastatic or Locally Unresectable Malignancies Who Are Undergoing Peripheral Stem Cell Transplantation

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Amifostine in Treating Patients With Metastatic or Unresectable Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Supportive care, Treatment Closed 18 to 55 Pharmaceutical / Industry DFCI-98068
ALZA-97-038-ii, NCI-V98-1491, NCT00003657

Objectives

I. Describe the toxic effects of ifosfamide, carboplatin, and etoposide (ICE) 
with amifostine in patients with metastatic or locally unresectable 
malignancies who are undergoing peripheral stem cell transplantation.

II. Describe the pharmacokinetic profile for ifosfamide and its metabolites in 
patients receiving the maximum tolerated dose of ICE with amifostine.

III. Compare the toxic effects of this study with the toxic effects observed 
on protocol 94-078. 

IV. Compare the pharmacokinetics of ifosfamide on this study with the 
pharmacokinetics observed on protocol 94-078.

Entry Criteria

Disease Characteristics:


Histologically proven metastatic or locally unresectable malignancy

Patient may be responding to therapy:
  Stage IIIC/IV or recurrent/refractory ovarian carcinoma (ineligible for
   other bone marrow or stem cell transplant protocols)
  Recurrent or refractory germ cell carcinoma
  Extensive disease small cell lung cancer in partial or complete remission
  Stage IIIB non-small cell lung cancer responding to chemotherapy
  Sarcomas in or near complete remission after induction chemotherapy
  Responsive bladder, head and neck carcinoma, or carcinoma of unknown primary
  Other tumors without curative or first line therapy (not eligible for phase
   II or III studies)

No active brain or bone marrow metastases

Prior/Concurrent Therapy:


Biologic therapy:
 Not specified   

Chemotherapy:
 Greater than 3 weeks since prior chemotherapy
 See Disease Characteristics
 No other concurrent chemotherapy

Endocrine therapy:
 Not specified   

Radiotherapy:
 Greater than 1 week since prior radiotherapy
 No concurrent radiotherapy

Surgery:
 Greater than 1 week since prior surgery (except for biopsies)

Other: 
 No barbiturates, dilantin, or cimetidine within 3 weeks of high dose
  chemotherapy
 No antihypertensive medications within 24 hours prior to amifostine
  administration

Patient Characteristics:


Age:
 18 to 55  

Performance status:
 PS 0-1 

Life expectancy:
 Not specified   

Hematopoietic:
 WBC at least 3,000/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Bilirubin no greater than 1.5 times upper limit of normal (ULN)
 SGOT less than 2.5 times ULN
  
Renal:
 Creatinine no greater than 1.5 times ULN
 Creatinine clearance at least 60 mL/min

Cardiovascular:
 No uncontrolled or severe cardiovascular disease
 No myocardial infarction within 6 months
 No congestive heart failure 

Other:
 Not pregnant
 No other serious medical or psychological illnesses
 No active uncontrolled bacterial, viral, or fungal infection
 No active duodenal ulcer

Expected Enrollment

A total of 25 evaluable patients will be accrued for this study within 19 
months.

Outline

Patients undergo peripheral blood stem cell (PBSC) harvest on day -8, followed 
by ifosfamide IV, carboplatin IV, and etoposide IV (ICE) by 96 hour continuous 
infusion on days -7 to -4. Patients receive amifostine IV twice a day on days 
-7 to -3. PBSCs are reinfused on day 0. Filgrastim (G-CSF) is administered 
subcutaneously beginning on day 0 at least 2 hours after infusion of the stem 
cells and continuing until blood cell counts recover.

Patients are followed monthly for the first 2 months and then for survival.

Published Results

Elias AD, Richardson P, Tretyakov O, et al.: Amifostine with high dose infosfamide, carboplatin, and etoposide (ICE) with hematopoietic STEM cell support. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A197, 2000.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Paul Richardson, MD, Protocol chair
Ph: 617-632-2104; 866-790-4500
Email: paul_richardson@dfci.harvard.edu

Registry Information

Official Title		High Dose Ifosfamide, Carboplatin and Etoposide with Amifostine Chemoprotection

Trial Start Date		1998-07-28

Registered in ClinicalTrials.gov		NCT00003657

Date Submitted to PDQ		1998-11-06

Information Last Verified		2006-05-18

NCI Grant/Contract Number		P30-CA06516

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.