Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Alternate Title

Acridine Carboxamide in Treating Patients With Advanced Ovarian Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over EORTC-16991O XENOVA-XR5000/015/98

Objectives

I. Determine the objective response, response rate, and duration of objective 
response in patients with advanced ovarian cancer treated with acridine 
carboxamide.

II. Determine the toxicity and pharmacokinetics of this regimen in these 
patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed ovarian cancer

Metastatic or inoperable, locally advanced, progressive disease

Must have failed treatment within 1 year of first line platinum and
taxane-based therapeutic regimen for advanced disease

At least 1 bidimensionally measurable target lesion by CT scan

No symptomatic brain metastasis

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified 

Chemotherapy:
 See Disease Characteristics
 At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and
  mitomycin)

Endocrine therapy:
 Not specified

Radiotherapy:
 At least 4 weeks since prior radiotherapy

Surgery:
 At least 14 days since prior major surgery

Other:
 No other concurrent anticancer agents
 No other concurrent investigational therapy

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-2

Life expectancy:
 At least 3 months

Hematopoietic:
 WBC greater than 3,000/mm3
 Platelet count greater than 100,000/mm3

Hepatic:
 Bilirubin less than 1.5 times upper limit of normal (ULN)
 Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver
  metastasis present)
 Transaminases no greater than 2 times ULN (5 times ULN if liver metastasis
  present)

Renal:
 Creatinine no greater than 1.7 mg/dL

Cardiovascular:
 Clinically normal cardiac function
 No prior ischemic heart disease within the past 6 months
 Normal 12 lead electrocardiogram

Other:
 No other prior or concurrent malignancy except cone-biopsied carcinoma of
  the cervix or adequately treated basal cell or squamous cell skin cancer
 No unstable systemic disease
 No active uncontrolled infection
 No concurrent psychological, familial, sociological, or geographical
  condition that would preclude study
 Not pregnant or nursing
 Fertile patients must use effective contraception

Expected Enrollment

A total of 14-25 patients will be accrued for this study.

Outline

This is a multicenter study.

Patients receive acridine carboxamide IV continuously over days 1-5.  
Treatment repeats every 21 days for a maximum of 6 courses in the absence of 
disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression.

Dittrich C, Dieras V, Kerbrat P, et al.: Phase II study of XR5000 (DACA), an inhibitor of topoisomerase I and II, administered as a 120-h infusion in patients with advanced ovarian cancer. Invest New Drugs 21 (3): 347-52, 2003.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Veronique Dieras, MD, Protocol chair		Ph: 33-1-44-32-4675 Email: veronique.dieras@curie.net