A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Malcolm J. Moore, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
United States: Federal Government
Study ID:
CDR0000269586
NCT ID:
NCT00053924
Start Date:
May 2003
Completion Date:
Related Keywords:
- Pancreatic Cancer
- recurrent pancreatic cancer
- stage II pancreatic cancer
- adenocarcinoma of the pancreas
- stage III pancreatic cancer
- stage IV pancreatic cancer
- Pancreatic Neoplasms
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