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 I Treatment Completed 18 and over NCI NCI-91-C-122C NCI-MB-265, NCI-T91-0018N, T91-0018

Objectives

I.  Establish the MTD of cyclopentenylcytosine administered as a 24-hour 
continuous iv infusion every 21 days in patients with recurrent or metastatic 
carcinoma.

II.  Evaluate the toxicities of this drug administered on this schedule.

III.  Determine the pharmacokinetic profile of cyclopentenylcytosine.

IV.  Document any antitumor activity of cyclopentenylcytosine administered on 
this schedule.

V.  Measure the effects of cyclopentenylcytosine on CTP synthetase activity in 
peripheral blood mononuclear and bone marrow cells.

Entry Criteria

Disease Characteristics:

Recurrent or metastatic carcinoma that has failed all
effective therapies or for which no such therapy is available

Objectively measurable disease not required

Prior/Concurrent Therapy:

Biologic therapy:
  At least 4 weeks since prior immunotherapy or recovered
  from toxicities of such therapy

Chemotherapy:
  At least 4 weeks since prior chemotherapy (6 weeks for
  nitrosoureas, mitomycin, or suramin) or recovered from
  toxicities of such therapy

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 2 weeks since prior radiotherapy or recovered from
  toxicities of such therapy

Surgery:
  Recovery from any prior surgery required

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-2

Hematopoietic:
  AGC at least 2,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.6 mg/dl
  SGOT no greater than 136 U/liter

Renal:
  Creatinine no greater than 1.6 mg/dl

Other:
  No active, uncontrolled infection requiring antibiotics
  HIV antibody negative
  No other serious concurrent medical illness that would
     preclude protocol therapy
  No pregnant or nursing women
  Adequate contraception required of fertile patients

Expected Enrollment

It is anticipated that 12-24 patients will be entered and that 12-24 months 
will be required to complete the study.

Outline

Nonrandomized study.

Single-agent Chemotherapy.  Cyclopentenylcytosine, CPE-C, NSC-375575.

Politi P, Setser A, Bastian A, et al.: Pharmacologically guided phase I trial of cyclopentenyl cytosine (CPEC) with biochemical monitoring. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-369, 142, 1993.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Jean Grem, MD, Protocol chair(Contact information may not be current)		Ph: 301-496-4345