Perifosine in Treating Patients With Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00053924
• Other study ID #: PMH-PHL-015
• Secondary ID: CDR0000269586NCI
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: July 22, 2015
• Start date: May 2003

Study information

• Verified date: July 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced or metastatic pancreatic cancer.

Description:

OBJECTIVES:

• Determine the efficacy of perifosine, in terms of 6-month survival, in patients with advanced adenocarcinoma of the pancreas.

• Determine the safety and tolerability of this drug in these patients.

• Determine median survival time and the 1-year survival rate of patients treated with this drug.

• Determine the objective response rate (partial and complete), response duration, and time to progression in patients treated with this drug.

• Determine the toxicity of this drug in these patients.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

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

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• perifosine

Locations

Country	Name	City	State
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada,