Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	no age specified	NCI	EST-1283

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.

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 Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Daniel Haller, MD, Protocol chair		Ph: 215-662-6318