NCT00053924CompletedPhase 2
A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Locations
- 3
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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
- •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)
- •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
- •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
- •No prior GI surgery affecting absorption
- •No concurrent antiretroviral therapy for HIV-positive patients
- •No other concurrent investigational agents
- +1 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (3)
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