NCT00059982

Brief Summary

RATIONALE: Perifosine may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced, unresectable, or metastatic pancreatic cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_2 pancreatic-cancer

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

June 24, 2013

Status Verified

August 1, 2004

First QC Date

May 6, 2003

Last Update Submit

June 21, 2013

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreasstage II pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancer

Interventions

perifosineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas * Locally advanced, unresectable, or metastatic disease * Measurable disease * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 * 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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

MBCCOP-Our Lady of Mercy Cancer Center

The Bronx, New York, 10466, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Related Publications (1)

  • Marsh Rde W, Rocha Lima CM, Levy DE, Mitchell EP, Rowland KM Jr, Benson AB 3rd. A phase II trial of perifosine in locally advanced, unresectable, or metastatic pancreatic adenocarcinoma. Am J Clin Oncol. 2007 Feb;30(1):26-31. doi: 10.1097/01.coc.0000251235.46149.43.

    PMID: 17278891RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

perifosine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Robert de W. Marsh, MD

    University of Florida

    STUDY CHAIR

  • Caio Max S. Rocha Lima, MD

    H. Lee Moffitt Cancer Center and Research Institute

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

July 1, 2003

Study Completion

August 1, 2005

Last Updated

June 24, 2013

Record last verified: 2004-08

Locations

US(10)