Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

NCT ID: NCT00059982

Last Updated: 2013-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2005-08-31

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.

Detailed Description

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.

Conditions

Pancreatic Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

perifosine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Robert de W. Marsh, MD

Role: STUDY_CHAIR

University of Florida

Caio Max S. Rocha Lima, MD

Role:

H. Lee Moffitt Cancer Center and Research Institute

Locations

CCOP - Carle Cancer Center

Urbana, Illinois, United States

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Tufts - New England Medical Center

Boston, Massachusetts, United States

CCOP - Duluth

Duluth, Minnesota, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

MBCCOP-Our Lady of Mercy Cancer Center

The Bronx, New York, United States

CCOP - Merit Care Hospital

Fargo, North Dakota, United States

CCOP - Scott and White Hospital

Temple, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 17278891 (View on PubMed)

Other Identifiers

ECOG-E1202

Identifier Type: -

Identifier Source: secondary_id

CDR0000298994

Identifier Type: -

Identifier Source: org_study_id