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

Alternate Title

Perifosine in Treating Patients With Advanced Pancreatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI PMH-PHL-015 NCI-5983, 5983, NCT00053924

Objectives

1. Determine the efficacy of perifosine, in terms of 6-month survival, in patients with advanced adenocarcinoma of the pancreas.
2. Determine the safety and tolerability of this drug in these patients.
3. Determine median survival time and the 1-year survival rate of patients treated with this drug.
4. Determine the objective response rate (partial and complete), response duration, and time to progression in patients treated with this drug.
5. Determine the toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas not amenable to curative local therapy
  • Metastatic OR locally advanced



• No known brain metastases



• No ascites that required therapeutic paracentesis on at least 2 occasions within the past 6 weeks

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No more than 1 prior chemotherapy regimen for metastatic or locally advanced disease
  • Prior chemotherapy, given as a radiosensitizer, allowed in addition to single-line therapy
• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

• Not specified

Radiotherapy

• At least 3 weeks since prior radiotherapy likely to have myelotoxic effects (more than 3,000 cGy to fields including substantial marrow) and recovered

Surgery

• No prior GI surgery affecting absorption

Other

• No concurrent antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST/ALT no greater than 2.5 times ULN (5 times ULN with liver metastases)

Renal

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

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

Gastrointestinal

• No gastrointestinal (GI) tract disease resulting in the inability to take oral medication or a requirement for IV alimentation
• No uncontrolled inflammatory bowel disease
• No active peptic ulcer disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine
• No other active malignant disease that could interfere with interpretation of study results
• No ongoing active infection
• No other uncontrolled concurrent illness
• No psychiatric illness or social situation that would preclude study compliance

Expected Enrollment

A total of 17-37 patients will be accrued for this study within 15 months.

Outline

Patients receive oral perifosine daily for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

Trial Contact Information

Trial Lead Organizations

Princess Margaret Hospital

Malcolm Moore, MD, Protocol chair		Ph: 416-946-2263

Registry Information
Official Title		A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma
Trial Start Date		2003-05-29
Registered in ClinicalTrials.gov		NCT00053924
Date Submitted to PDQ		2002-12-09
Information Last Verified		2004-07-26
NCI Grant/Contract Number		CM17107