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

Eastern Cooperative Oncology Group

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: perifosine

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00059982

ECOG-E1202

CDR0000298994

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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