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Phase I Study of Carboplatin and Cyclophosphamide with Amifostine for Cytoprotection in Patients with Advanced Malignancies

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

Alternate Title

Combination Chemotherapy Plus Amifostine in Treating Patients With Advanced Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase I Supportive care, Treatment Closed 18 and over Pharmaceutical / Industry CCF-IRB-1907
IMMUNEX-001.G9701, NCI-V98-1424, NCT00004036

Objectives

I. Determine the effects of priming on the granulocyte and thrombocyte nadirs 
produced by high dose cyclophosphamide and carboplatin in patients with 
advanced malignancies.

II. Determine the effects of amifostine on the granulocyte and thrombocyte 
nadirs produced by this same regimen when administered with sargramostim 
primed progenitor cells.

III. Determine the maximum tolerated dose of cyclophosphamide and carboplatin 
that can be administered with sargramostim primed progenitor cells.

Entry Criteria

Disease Characteristics:


Histologically proven advanced malignancies that are sensitive to
cyclophosphamide/carboplatin therapy OR refractory to standard therapy,
including, but not limited to:

  Ovarian epithelial cancer           Colorectal cancer
  Breast cancer                       Sarcoma      
  Non-small cell lung cancer          Malignant melanoma
  Upper gastrointestinal cancers      Small cell lung cancer

Prior/Concurrent Therapy:


Biologic therapy:
 No concurrent immunotherapy

Chemotherapy:
 At least 3 weeks since prior chemotherapy and recovered
 No more than 1 prior chemotherapy regimen for advanced or recurrent           
  malignancies (not including adjuvant chemotherapy)
 No prior nitrosoureas or intravenous mitomycin
 No concurrent cytotoxic chemotherapy

Endocrine therapy:
 At least 1 week since prior hormone therapy and recovered
 Concurrent corticosteroid therapy allowed

Radiotherapy:
 At least 3 weeks since prior radiotherapy and recovered
 Radiotherapy allowed to no more than 1 site in the thoracic or lumbar spine   
  or pelvis
 Concurrent radiotherapy to a symptomatic lesion allowed after the first       
  course of study treatment

Surgery:
 At least 3 weeks since prior surgery and recovered (excluding recent biopsy   
  or placement of an intravenous access device)

Patient Characteristics:


Age:
 18 and over

Performance status:
 ECOG 0-2  
 SWOG 0-2

Life expectancy:
 At least 3 months

Hematopoietic:
 WBC at least 3,500/mm³
 Absolute neutrophil count at least 1,500/mm³
 Platelet count at least 100,000/mm³
 Hemoglobin at least 8.5 g/dL 

Hepatic:
 Bilirubin no greater than 1.5 mg/dL

Renal:
 Creatinine no greater than 1.5 mg/dL 
 OR
 Creatinine clearance at least 60 mL/min 
 OR
 Iothalamate clearance at least 60 mL/min

Cardiovascular:
 No significant coronary artery disease (angina of New York Heart Association  
  class 3 or greater)

Other:
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception
 No psychosis

Expected Enrollment

Approximately 24-30 patients will be accrued for this study within 1 year.

Outline

This is a dose escalation study.

Patients receive intravenous amifostine over 10 minutes on day 0, followed by 
intravenous cyclophosphamide and carboplatin consecutively over 5-15 minutes. 
Sargramostim is administered subcutaneously on days -7 to -2 and again 
beginning on day 1 until absolute neutrophil count is appropriate. Course is 
repeated every 28 days until disease progression or unacceptable toxic effects 
are observed. Nonresponding patients discontinue treatment after 2 courses. 
Patients are treated for a maximum of 6 courses.

Groups of 3-6 patients receive escalating doses of cyclophosphamide and 
carboplatin until the maximum tolerated dose (MTD) is determined. If dose 
limiting toxicity (DLT) occurs in 2 of 6 patients at a given dose level, then 
dose escalation ceases and the next lower dose is declared the MTD.

Trial Contact Information

Trial Lead Organizations

Cleveland Clinic Foundation Hospital

George Budd, MD, Protocol chair
Ph: 216-444-6480; 800-862-7798

Registry Information

Official Title		Phase I Trial of High Dose Chemotherapy Using Amifostine for In-Vivo Protection of GM-CSF Primed Progenitor Cells

Trial Start Date		1997-11-01

Registered in ClinicalTrials.gov		NCT00004036

Date Submitted to PDQ		1998-06-03

Information Last Verified		2007-05-23

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.