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

Alternate Title

Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI ECOG-E1202 NCT00059982, E1202

Objectives

1. Determine the activity of perifosine, in terms of objective response, in patients with locally advanced, unresectable, or metastatic pancreatic cancer.
2. Determine the response duration, progression-free survival, and overall survival of patients treated with this drug.
3. Determine the toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the pancreas



• Locally advanced, unresectable, or metastatic disease



• Measurable disease



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for pancreatic cancer
• More than 6 months since prior chemotherapy for other diseases

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy and recovered

Surgery

• At least 4 weeks since prior surgery and recovered

Other

• No other concurrent investigational agents for pancreatic cancer
• No concurrent combination antiretroviral therapy for HIV-positive patients

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic

• AST no greater than 2 times upper limit of normal (ULN)
• Bilirubin no greater than 2 times ULN

Renal

• Creatinine no greater than 1.4 mg/dL

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other concurrent illness that would preclude study participation

Expected Enrollment

A total of 35-84 patients will be accrued for this study within 21 months.

Outline

This is a multicenter study.

Patients receive oral perifosine every 6 hours for a total of 6 doses and then once daily in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 3 years.

Marsh Rde W, Lima CM, Levy DE, et al.: A phase II trial of perifosine in locally advanced, unresectable, or metastatic pancreatic adenocarcinoma. Am J Clin Oncol 30 (1): 26-31, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Robert Marsh, MD, Protocol chair		Ph: 352-273-7760
Caio Max Rocha Lima, MD, Protocol co-chair		Ph: 813-558-1667; 888-663-3488 Email: rochalcm@moffitt.usf.edu

Registry Information
Official Title		Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma
Trial Start Date		2003-07-10
Registered in ClinicalTrials.gov		NCT00059982
Date Submitted to PDQ		2003-03-12
Information Last Verified		2004-08-26
NCI Grant/Contract Number		U10-CA21115

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