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 GOG-26J

Objectives

I.  Determine the efficacy of Yoshi-864 for advanced pelvic malignancies 
resistant to current high-priority methods of treatment.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed, measurable, recurrent, persistent local or metastatic gynecologic 
cancer with documented disease progression who are not eligible for a higher 
priority protocol.  Patients must have:  GOG performance status no higher than 
2; recovered from effects of recent surgery, radiotherapy, or chemotherapy 
(off chemotherapy for at least 3 weeks); adequate bone marrow and renal 
function; and bilirubin less than 1.2 mg%.  (Patients with abnormal liver 
function tests secondary to metastatic tumor are eligible per Amendment, 
January 1981.) Protocol closed to patients with epithelial ovarian carcinoma 
in February 1981.  A steady rise in the titers of alpha-fetoprotein and 
beta-HCG will be taken as evidence of disease progression in germ cell tumors 
of the ovary, per November 1981 amendment.

Expected Enrollment

25 patients per disease site will be entered (64 total as of January 1982).  
Protocol closed 10/82.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Yoshi-864, YOSHI, NSC-102627.

Slavik M, Muss H, Blessing JA: Phase II clinical study of Yoshi 864 in squamous cell carcinoma of the uterine cervix. Cancer Treat Rep 67 (2): 195-6, 1983.[PUBMED Abstract]

Slavik M, Muss H, Blessing JA, et al.: Phase II clinical study of Yoshi 864 in epithelial ovarian carcinoma: A Gynecologic Oncology Group Study. Cancer Treat Rep 66 (9): 1775-7, 1982.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

George Lewis, MD, Protocol chair		Ph: 215-955-8461; 800-533-3669 Email: 73522.1357@compuserve.com