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Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma


OBJECTIVES:

- Determine the activity of perifosine, in terms of objective response, in patients with
locally advanced, unresectable, or metastatic pancreatic cancer.

- Determine the response duration, progression-free survival, and overall survival of
patients treated with this drug.

- Determine the toxicity of this drug in these patients.

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.

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robert de W. Marsh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Florida

Authority:

United States: Federal Government

Study ID:

CDR0000298994

NCT ID:

NCT00059982

Start Date:

July 2003

Completion Date:

August 2005

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
CCOP - Scott and White HospitalTemple, Texas  76508
Tufts - New England Medical CenterBoston, Massachusetts  02111
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466