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

Alternate Title

Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 18 and over NCI CHNMC-04090 NCT00233948

Special Category: NCI Web site featured trial

Objectives

1. Determine the maximum tolerated dose of nelfinavir mesylate in patients with recurrent, metastatic, or unresectable liposarcoma. (Phase I)
2. Determine the pharmacokinetics of this drug in these patients. (Phase I)
3. Determine the response rate and progression-free survival of patients treated with this drug. (Phase II)

Entry Criteria

Disease Characteristics:

• Histologically confirmed liposarcoma
  • Recurrent, metastatic, or unresectable disease



• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Pleural effusions and ascites are not considered measurable disease



• Brain metastases allowed provided they are successfully controlled by surgery or radiotherapy

Prior/Concurrent Therapy:

Biologic therapy

• At least 3 weeks since prior biologic therapy
• No concurrent immunotherapy

Chemotherapy

• At least 3 weeks since prior chemotherapy and recovered
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent oral contraceptives

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• At least 3 weeks since prior surgery

Other

• At least 3 weeks since other prior therapy
• No prior or other concurrent HIV protease inhibitors
• No other concurrent investigational agents
• No other concurrent anticancer therapy
• No concurrent treatment with any of the following medications:
  • Astemizole
  • Cisapride
  • Triazolam
  • Midazolam
  • Ergot derivatives
  • Amiodarone
  • Quinidine
  • Dihydropyridine calcium antagonists
  • Sildenafil
  • Dilantin
  • Rifampin

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 75,000/mm³

Hepatic

• Bilirubin ≤ 2.0 mg/dL
• AST and ALT ≤ 2.0 times upper limit of normal

Renal

• Not specified

Other

• Not pregnant
• Fertile patients must use effective barrier contraception
• No other uncontrolled illness

Expected Enrollment

A total of 40 patients will be accrued for this study.

Outcomes

Maximum tolerated dose
Response rate as measured by RECIST criteria

Progression-free survival at 4 months
Response correlated with surrogate markers

Outline

This is a phase I dose-escalation study followed by a phase II study.

• Phase I: Patients receive oral nelfinavir mesylate twice daily in the absence of disease progression or unacceptable toxicity.

  Cohorts of 3-6 patients receive escalating doses of nelfinavir mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.




• Phase II: Patients receive nelfinavir mesylate as in phase I at the MTD.

Trial Contact Information

Trial Lead Organizations

City of Hope Comprehensive Cancer Center

Clinical Trials Office - New Patient Services		Ph: 800-826-4673 Email: becomingapatient@coh.org

U.S.A.
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org

Related Information

Featured trial article

Registry Information
Official Title		Phase I/II Study of Nelfinavir in Liposarcoma
Trial Start Date		2006-03-29
Registered in ClinicalTrials.gov		NCT00233948
Date Submitted to PDQ		2005-06-22
Information Last Verified		2008-08-08
NCI Grant/Contract Number		FD003006-01, CA33572