NCT00044785

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2002

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2005

First QC Date

September 4, 2002

Last Update Submit

June 23, 2005

Conditions

Solid Tumors

Keywords

colorectal cancergastric cancerbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Safety and Maximum Tolerated Dose

Interventions

triacetyluridineDRUG
fluorouracilDRUG
leucovorinDRUG
camptosarDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsStomach NeoplasmsBreast Neoplasms

Interventions

uridine triacetateFluorouracilLeucovorinIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCamptothecinAlkaloids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 4, 2002

First Posted

September 6, 2002

Study Start

August 1, 2002

Study Completion

March 1, 2004

Last Updated

June 24, 2005

Record last verified: 2005-05

Locations

US(1)