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 18 and over NCI SWOG-8904 SWOG-8904

Objectives

I.  Evaluate the response rates in patients with recurrent epithelial 
carcinoma of the ovary randomized to merbarone vs. piroxantrone.
II.  Evaluate the toxicity associated with each regimen.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age 
with recurrent, histologically proven epithelial carcinoma of the ovary.  
Patients must have had 1 or 2 prior chemotherapy regimens, which may have 
contained cisplatin and/or carboplatin, and must have had no response or 
progressive disease after treatment.  The cumulative dose of prior doxorubicin 
or mitoxantrone must not have reached 250 mg/sqm or 50 mg/sqm, respectively.  
Patients may have received prior surgery or radiotherapy (provided irradiation 
was to less than 25% of the bone marrow) and no more than 1 prior biological 
response modifier.  At least 3 weeks must have elapsed since prior 
chemotherapy, radiotherapy, or biologic therapy, and the nadirs of leukopenia 
and thrombocytopenia must be surpassed with evidence of hematologic recovery.  
Patients must have bidimensionally measurable disease with clearly defined 
margins on x-ray or CT scan with at least 1 dimension greater than 0.5 cm 
(bone lesions excluded) or palpable lesions with both diameters at least 2 cm. 
 A SWOG performance status of 2 or better is required as are adequate 
parameters of bone marrow and liver function:  granulocytes at least 2,000, 
platelets within institutional normal limits, and serum bilirubin within 
institutional normal limits.  An LVEF of at least 45% as measured by MUGA scan 
is required.  Patients with an MI within the past 6 months, a history of CHF, 
angina pectoris, or serious arrhythmias that require medical treatment are 
ineligible.  Patients must have had no prior second malignancy except 
adequately treated basal or squamous cell skin cancer, in situ cervical 
cancer, and other cancer from which the patient has been disease free for 5 
years.  Women who are pregnant or lactating are ineligible, and women of 
childbearing potential must practice adequate contraception.  Bloodwork and 
other body fluid analyses for eligibility determination and imaging studies 
and physical examination for tumor measurement must be completed within 14 
days prior to registration; screening exams other than blood/body fluid 
analyses and imaging studies of nonmeasurable disease or uninvolved organs 
must be completed within 42 days prior to registration.

Expected Enrollment

If at least one response is observed in the first 15 patients, an additional 
15 patients will be entered.  An accrual rate of about 27 patients per year is 
anticipated.

Outline

Randomized study.
Arm I (arm closed as of 02/91):  Single-agent Chemotherapy.  Merbarone, MERB, 
NSC-336628.
Arm II:  Single-agent Chemotherapy.  Piroxantrone, PXT, NSC-349174.

Albain KS, Liu PY, Hantel A, et al.: A phase II trial of piroxantrone in advanced ovarian carcinoma after failure of platinum-based chemotherapy: Southwest Oncology Group Study 8904. Gynecol Oncol 57 (3): 407-11, 1995.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Kathy Albain, MD, Protocol chair		Ph: 708-327-3304 Email: kalbain@lumc.edu