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 III, Phase II Treatment Closed under 70 NCI SWOG-8040/43 SWOG-8043

Objectives

I.  Determine the antitumor activity of DHAD, as determined by response rate 
and duration of response, given on a single-dose every-three-weeks schedule in 
patients with advanced adenocarcinoma of the pancreas.
II.  Determine additional information concerning the nature and degree of 
toxicity of this drug.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed adenocarcinoma of the exocrine pancreas with distant metastases 
(liver, peritoneum, etc.) or with localized disease not amenable to curative 
surgery or radiotherapy.  There must be objectively measurable disease.  
Patients must be under 70 years of age and have a life expectancy of at least 
10 weeks.  The performance status must be at worst Grade 3 by SWOG criteria; 
hematologic and renal function must be adequate.  Patients may not have 
received prior chemotherapy or radiotherapy.  Therapy on this protocol should 
begin not less than 3 weeks after any prior surgery.  (Per Addendum 1, July 
1981, patients whose cumulative dose of prior adriamycin exceeds 400 mg/sqm 
are ineligible, and cardiac monitoring must be done in those who have received 
a prior total dose of 350 mg/sqm; ejection fractions must be within normal 
limits.  A past history of heart disease is cause for exclusion.)  This 
protocol is Appendix VII of SWOG-8040 (master protocol).  DHAD is the second 
Phase II agent to be evaluated on this master study.

Expected Enrollment

25 patients will be treated on the arm described in this protocol.  The DHAD 
arm closed temporarily in May 1983 for evaluation of data; there is a 
possibility it will be reopened.  Protocol permanently closed August 1984.

Outline

Randomized study.
Arm I:  4-Drug Combination Chemotherapy with FAM-S.  See SWOG-8040.
Arm II:  Single-agent Chemotherapy.  Dihydroxyanthracenedione, DHAD, 
NSC-301739.

Bukowski RM, Fleming TR, Macdonald JS, et al.: Evaluation of combination chemotherapy and phase II agents in pancreatic adenocarcinoma. A Southwest Oncology Group study. Cancer 71 (2): 322-5, 1993.[PUBMED Abstract]

Taylor SA, Fleming T, Von Hoff DD, et al.: Phase II evaluation of mitoxantrone in advanced pancreatic carcinoma: a Southwest Oncology Group study. Invest New Drugs 8 (1): 77-80, 1990.[PUBMED Abstract]

Bukowski RM, Inamasu M, Taylor S, et al.: Randomized trial of combination chemotherapy vs. a phase II drug in metastatic adenocarcinoma of the pancreas: Southwest Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 4: C-311, 80, 1985.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Charles Coltman, MD, Protocol chair(Contact information may not be current)		Ph: 210-567-2710