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	GOG-26P

Objectives

I.  Screen new agents or drug combinations for activity in patients with 
advanced or recurrent pelvic malignancies using a rejection-type study design 
(Master Protocol GOG-26).
II.  Determine, in this portion of Master Protocol GOG-26, the efficacy of 
AT-125 in patients with advanced or recurrent pelvic malignancies that are 
resistant to higher 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, advanced, recurrent, persistent, metastatic or local gynecologic 
cancer with documented disease progression who are not eligible for higher 
priority protocols.  There must be measurable lesions that can be followed for 
tumor response.  Patients must have a GOG performance grade of 0, 1, or 2, and 
there must be adequate bone marrow (granulocyte count at least 2,000/cumm and 
platelets at least 150,000/cumm), renal (BUN at most 25 mg%, creatinine at 
most 1.5 mg%), and hepatic (bilirubin at most 1.0 mg%, SGOT at most 50 IU) 
function.  Patients with abnormal liver function due to metastatic liver tumor 
are eligible.  Patients must have recovered from the effects of recent 
surgery, radiotherapy, or chemotherapy; they may have received no chemotherapy 
for 3 weeks prior to entry.  There must be no prior treatment with the study 
agent.  Patients with cervical and endometrial cancer are allowed only one 
prior chemotherapy trial; patients with ovarian cancer, uterine sarcoma, or 
other gynecologic malignancies are allowed no more than two prior chemotherapy 
trials.  Patients with a history of seizures and/or psychosis are ineligible.

Expected Enrollment

25 evaluable patients per disease site are required.  Because of reported 
toxicities, an immediate hold was placed on patient entry in October 1983.  
Protocol closed to patient entry February 1984.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Acivicin, AT-125, NSC-163501.

McGuire WP, Blessing JA, DiSaia PJ, et al.: Phase II trial of acivicin in patients with advanced epithelial ovarian carcinoma. A Gynecologic Oncology Group Study. Invest New Drugs 4 (1): 49-52, 1986.[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