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	Closed	no age specified	NCI	SWOG-7735

Objectives

I.  Determine the efficacy of anguidine and survival in terms of response rate 
and median duration of response in the treatment of advanced gastrointestinal 
malignancies.
II.  Observe any factors predisposing to excessive myelosuppression and for 
other toxicities not observed during Phase I studies of this drug.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with surgically incurable 
measurable disease of histologically confirmed gastrointestinal malignancy, 
exiting from or not eligible for higher priority studies.  Patients must not 
have had extensive radiation, chemotherapy or GI surgery in the last 3 weeks 
before study entry.  A life expectancy of more than 6 weeks, serum creatinine 
below 2.0 mg%, BUN below 30 mg% and serum bilirubin less than 6.0 mg% are 
required.  Poor-risk patients are those more than 65 years old, those with 
poor tolerance to prior chemotherapy, with extensive prior radiotherapy to 
myeloproliferative areas, with 3.0 to 6.0 mg% serum bilirubin or hepatic 
enzyme elevation.

Expected Enrollment

Protocol closed 10/79.

Outline

Nonrandomized study.  Single-agent Chemotherapy.  Anguidine, ANG, NSC-141537.

Bukowski R, Vaughn C, Bottomley R, et al.: Phase II study of anguidine in gastrointestinal malignancies: a Southwest Oncology Group study. Cancer Treat Rep 66 (2): 381-3, 1982.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

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