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Phase I Study of PN401, Fluorouracil, Leucovorin and CPT-11 in Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044785
Recruitment Status : Terminated
First Posted : September 6, 2002
Last Update Posted : June 24, 2005
Information provided by:
Wellstat Therapeutics

Brief Summary:
CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU, leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well tolerated and therefore potentially increase effectiveness.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: triacetyluridine Drug: fluorouracil Drug: leucovorin Drug: camptosar Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Escalating Doses of CPT-11 and 5fluorouracil (5FU) Plus PN401 With a Fixed Dose of Leucovorin in Patients With Solid Tumor Malignancies.
Study Start Date : August 2002
Study Completion Date : March 2004

Primary Outcome Measures :
  1. Safety and Maximum Tolerated Dose

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Must be at least 18 years of age;
  • Life expectancy: At least 3 months;
  • Performance status: ECOG of 0 or 1;
  • Histologic or cytologic proof of a solid tumor cancer that is not amenable to curative surgical resection;
  • Evaluable or measurable disease documented within 4 weeks of the start of treatment;
  • Prior chemotherapy or radiotherapy is allowed if 4 weeks or more have elapsed prior to starting treatment and patients have recovered from toxicities of prior treatment;
  • Adequate organ function:

Hematopoietic: ANC = 1500/ul or more, Platelets = 100,000/ul or more, Hemoglobin = 9.5 g/dL or more, transfusion prior to evaluation is allowed; Hepatic: Bilirubin = 2.0 mg/dL or less and SGPT(ALT) and SGOT(AST) < 3 x upper limit of normal (< 5 x upper limit of normal if liver metastases present) Renal: Serum Creatinine < 2.0 mg/dL;

  • Patient has the initiative, geographic proximity, and means to be compliant with the protocol;
  • Fertile patients (male or female) must agree to use effective contraception;
  • Must be able to swallow and retain tablets.

Exclusion Criteria

  • Major surgery within the four weeks preceding the start of treatment;
  • Serious medical or psychiatric illness that would prevent self-determined informed consent;
  • Intensive chemotherapy treatment;
  • Infection or antibiotics at the time of screening;
  • Uncontrolled cardiovascular, pulmonary, renal, neurologic, psychiatric, or hepatic dysfunction;
  • Pregnant or nursing;
  • Pre-existing diarrhea or uncontrolled clinically significant illness other than cancer (i.e. ulcerative colitis, malabsorption syndrome);
  • Brain metastases that have not been stable for more than 3 months;
  • Known Dihydropyrimidine Dehydrogenase (DPD) deficiency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044785

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United States, Maryland
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Wellstat Therapeutics

Layout table for additonal information Identifier: NCT00044785     History of Changes
Other Study ID Numbers: 401.02.001
First Posted: September 6, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2005

Keywords provided by Wellstat Therapeutics:
colorectal cancer
gastric cancer
breast cancer

Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors