|
Perifosine in Treating Patients With Advanced Pancreatic Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Perifosine in Treating Patients With Advanced Pancreatic Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Perifosine in Treating Patients With Advanced Pancreatic Cancer Clinical research trials and Perifosine in Treating Patients With Advanced Pancreatic Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Perifosine in Treating Patients With Advanced Pancreatic Cancer. Perifosine in Treating Patients With Advanced Pancreatic Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Perifosine in Treating Patients With Advanced Pancreatic Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Perifosine in Treating Patients With Advanced Pancreatic Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Perifosine in Treating Patients With Advanced Pancreatic Cancer  Perifosine in Treating Patients With Advanced Pancreatic Cancer
Perifosine in Treating Patients With Advanced Pancreatic Cancer
For Condition: recurrent pancreatic cancer,adenocarcinoma of the pancreas,stage 3 pancreatic cancer,stage 4B pancreatic cancer,stage 4A pancreatic cancer,stage 2 pancreatic cancer
Status: Recruiting
Sponsor(s): Princess Margaret Hospital , National Cancer Institute (NCI)
Synopsis: 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 metastaticpancreatic cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MalcolmMoore, Study Chair, Princess Margaret Hospital
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Ian Kerr 519-685-8500
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Malcolm Moore 416-946-2263
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Pierre Major 905-387-9711 ext. 64603
Additional Information:
Study ID Numbers: CDR0000269586; NCI-5983,PMH-PHL-015
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053924
Other Adenocarcinoma Of The Pancreas Studies:
1. Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer
2. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery
3. CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
4. BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
5. Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer
Related Studies:
Other adenocarcinoma of the pancreas Clinical Trials
Other Ontario Clinical Trials
Other Hamilton Clinical Trials
Perifosine in Treating Patients With Advanced Pancreatic Cancer
|
|
|
|
|
|
|
|
