Pancreatic Cancer
Conditions
Keywords
recurrent pancreatic cancer, stage II pancreatic cancer, adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer
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.
Interventions
DRUGperifosine
Sponsors
National Cancer Institute (NCI)
University Health Network, Toronto
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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: 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
Countries
Canada
Outcome results
None listed