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Phase III Randomized Study of Weekly Intravenous P-30 Protein plus Daily Oral Tamoxifen vs Weekly Intravenous Gemcitabine for Advanced Pancreatic Cancer (Summary Last Modified 08/98)
Alternate Title Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer
Objectives I. Compare the efficacy of weekly intravenous P-30 protein plus daily oral tamoxifen vs. weekly intravenous gemcitabine in patients with stage III/IV, measurable or evaluable pancreatic cancer. II. Compare the safety of these two treatments. III. Compare survival, progression-free survival, and quality of life in patients on these two regimens. Entry Criteria Disease Characteristics: Histologically confirmed adenocarcinoma of the pancreas Stage III/IV disease with documented progression No CNS metastases Measurable or evaluable disease Evaluable disease not eligible for response determination and defined as: Multiple lesions too numerous to measure Liver span in right mid-clavicular line The following alone may not be measurable nor evaluable: Ascites Elevated tumor markers Prior/Concurrent Therapy: Prior radiotherapy with or without fluorouracil allowed Prior surgery allowed Patient Characteristics: Age: 21 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than twice normal PT, PTT, and fibrinogen normal Renal: Creatinine normal Cardiovascular: No NYHA class II-IV status No congestive heart failure No angina pectoris No arrhythmia No uncontrolled hypertension Metabolic: No uncontrolled diabetes mellitus, i.e.: Fasting blood glucose greater than 300 mg/dL Any degree of metabolic acidosis No other significant metabolic abnormality, e.g., in serum calcium, phosphate, or other electrolytes Other: No uncontrolled, serious infection No uncontrolled psychiatric disorder No uncontrolled seizure disorder or other neurologic disease No senility or emotional instability that precludes patient cooperation No pregnant or nursing women Effective contraception required of fertile patients Expected Enrollment 150 patients will be entered over 18 months to obtain 120 evaluable patients for this multicenter study. Outline Randomized study. Group I: Single-Agent Chemotherapy plus Antiestrogen Therapy. P-30 Protein (Onconase); plus Tamoxifen, TMX, NSC-180973. Group II: Single-Agent Chemotherapy. Gemcitabine, dFdC, NSC-613327. Trial Lead Organizations Alfacell Corporation
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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