Perifosine in Treating Patients With Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053924
First received: February 5, 2003
Last updated: July 23, 2008
Last verified: July 2004

February 5, 2003
July 23, 2008
May 2003
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Complete list of historical versions of study NCT00053924 on ClinicalTrials.gov Archive Site
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Perifosine in Treating Patients With Advanced Pancreatic Cancer
A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
Drug: perifosine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00053924
CDR0000269586, PMH-PHL-015, NCI-5983
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Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Study Chair: Malcolm J. Moore, MD Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP