Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over EORTC-16944O

Objectives

I.  Determine whether partial or complete responses can be achieved with 
GI147211 (a camptothecin analogue) in patients with refractory or recurrent 
ovarian epithelial cancer.

II.  Assess the probability that the actual response rate to GI147211 warrants 
further study in patients with this tumor type.

III.  Characterize the toxicity of this treatment.

IV.  Characterize the pharmacokinetics/pharmacodynamics of GI147211 in these 
patients.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed ovarian epithelial carcinoma,
including:
  Serous            Clear cell
  Mucinous          Undifferentiated adenocarcinoma
  Endometroid

Locally advanced, unresectable, or metastatic disease
  Histologic or cytologic proof of recurrence required for a single metastasis
  at a new site

Disease progression within 1 year of last chemotherapy

Bidimensionally measurable, previously unirradiated lesion
  New lesion in a prior radiotherapy field acceptable

The following are not considered measurable
  Ascites
  Pleural effusion
  Bone metastases
  Palpable but unmeasurable abdominal mass

No Brenner tumor

No low malignant potential (borderline) tumors

No brain or leptomeningeal disease

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  At least 1 and no more than 2 prior regimens required
     Prior platinum required
     Change of platinum except for toxicity considered 2 regimens
     First-line regimen repeated as second-line therapy considered 2 regimens
     No prior nitrosoureas
     No prior mitomycin
     No prior camptothecin or its analogues
     No prior myeloablative chemotherapy with marrow or peripheral stem cell
        transplantation
  At least 4 weeks since chemotherapy
  No concurrent cytotoxic agents

Endocrine therapy:
  No concurrent hormonal therapy

Radiotherapy:
  At least 4 weeks since radiotherapy (8 weeks if extensive)

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  WHO 0-2

Life expectancy:
  At least 3 months

Hematopoietic:
  WBC at least 3,000
  Platelets at least 100,000
  Hb at least 9.5 g/dl

Hepatic:
  Bilirubin no greater than 1.5 mg/dl (26 micromoles/liter)
  SGOT and SGPT no greater than 2 x ULN (unless liver involved with tumor)
  Alkaline phosphatase no greater than 2 x ULN (unless liver involved with
     tumor)

Renal:
  Creatinine no greater than 1.6 mg/dl (140 micromoles/liter) 
  Creatinine clearance at least 60 ml/min if creatinine 1.1-1.6 mg/dl (100-140
     micromoles/liter)

Cardiovascular:
  No history of CHF unless LVEF normal by MUGA
  No active heart disease requiring antiarrhythmics

Other:
  No active peptic ulcer disease within 6 months
  No pancreatitis within 6 months
  Guaiac-negative stool
  No uncontrolled infection
  No prior or concurrent second malignancy except:
     Adequately treated nonmelanomatous skin cancer
     Cone-biopsied in situ carcinoma of the cervix
  Adequate contraception required of fertile patients during and for 3 months
     after study

Expected Enrollment

40 patients will be entered.  If none of the first 20 patients responds, the 
study will close.

Outline

Single-Agent Chemotherapy.  GI147211 (a camptothecin analogue).

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Allan van Oosterom, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 32-16-34-3322-11