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Phase II Master Protocol for Evaluation of New Treatments in Patients with Residual, Recurrent, or Metastatic Pancreatic Adenocarcinoma --- DHAD vs ACM vs SPG vs VP-16
Basic Trial Information
Objectives I. Evaluate new agents or combinations in the treatment of advanced adenocarcinoma of the pancreas. II. Evaluate, in this protocol, dihydroxyanthracenedione, aclacinomycin-A, spirogermanium, and VP-16 as single agents. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with known pancreatic carcinoma beyond the hope of surgical cure who have histologic proof of residual, recurrent, or metastatic cancer and who have a measurable area of known metastatic disease to serve as indicator. The performance status must be 0-2, and there must be adequate nutritional status and adequate bone marrow, liver, and kidney function. There may have been no prior chemotherapy, no radiotherapy within 1 month (except palliative treatment to lesions not used for measurement and not involving large areas of bone), no major surgery with resection and anastomosis within 3 weeks, and no exploratory surgery with biopsy within 2 weeks. Patients may not have a history of congestive heart failure, ischemic heart disease, cardiac arrhythmia, myocardial infarction within 6 months, angina, evidence of myocardial insufficiency, or, if performed, an ejection fraction of less than normal as assessed by radionuclide cardiac scan. Expected Enrollment 25 patients will be entered on each arm over about 2.5 years. Outline Randomized study. Arm I: Single-agent Chemotherapy. Dihydroxyanthracenedione, DHAD, NSC-301739. Arm II: Single-agent Chemotherapy. Aclacinomycin-A, ACM, NSC-208734. Arm III: Single-agent Chemotherapy. Spirogermanium, SPG, NSC-192965. Arm IV: Single-agent Chemotherapy. VP-16213, VP-16, NSC-141540.Published Results Asbury RF, Cnaan A, Johnson L, et al.: An Eastern Cooperative Oncology Group phase II study of single agent DHAD, VP-16, aclacinomycin, or spirogermanium in metastatic pancreatic cancer. Am J Clin Oncol 17 (2): 166-9, 1994.[PUBMED Abstract] Trial Lead Organizations Eastern Cooperative Oncology Group
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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