Perifosine in Treating Patients With Advanced Pancreatic Cancer - Full Text View

Sponsor:	Princess Margaret Hospital, Canada
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00053924

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: perifosine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Perifosine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 2003

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053924

Locations

Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

Princess Margaret Hospital, Canada

National Cancer Institute (NCI)

Investigators

Study Chair:

Malcolm J. Moore, MD

Princess Margaret Hospital, Canada

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000269586, PMH-PHL-015, NCI-5983
Study First Received:	February 5, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00053924 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent pancreatic cancer
stage II pancreatic cancer
adenocarcinoma of the pancreas
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009