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-16944C

Objectives

I.  Determine whether partial or complete responses can be achieved with 
GI147211 (a camptothecin analogue) in patients with advanced colorectal 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 colorectal cancer that is locally
advanced, unresectable, or metastatic
  Documented progression prior to entry
  Stool guaiac negative prior to entry

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

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

No brain or leptomeningeal disease

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior camptothecin or its analogues
  No prior chemotherapy for advanced disease
  At least 12 months since adjuvant fluorouracil, leucovorin, or levamisole
  At least 30 days since other investigational cytotoxic drugs

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior or concurrent irradiation of lesions in, on, or around the true
     bony pelvis
  For rectal tumors:
     No prior or concurrent curative or adjuvant radiotherapy
     No prior or concurrent extensive palliative radiotherapy

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)

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 within 6 months
  No pancreatitis within 6 months
  No uncontrolled infection
  No prior or concurrent second malignancy except adequately treated:
     Cone-biopsied carcinoma in situ of the cervix
     Nonmelanomatous skin cancer
  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

T. Gamucci, MD, Protocol chair(Contact information may not be current)		Ph: 39-06-5266-5607