Solid TumorsPhase 1NCT00044785
Phase I Study of PN401, Fluorouracil, Leucovorin and CPT-11 in Patients With Solid Tumors
A Phase 1 study testing triacetyluridine, fluorouracil and leucovorin in people with Solid Tumors, run by Wellstat Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- triacetyluridine, fluorouracil and leucovorin
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Mar 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201
About this study
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.
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.
- Conditions
- Solid Tumors
- Being tested
- triacetyluridine, fluorouracil, leucovorin, camptosar
- Keywords
- colorectal cancer, gastric cancer, breast cancer
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triacetyluridineDrug
fluorouracilDrug
leucovorinDrug
camptosarDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Maximum Tolerated Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2002 (estimated)
- Study startAug 2002
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Wellstat Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044785
- Sponsor's protocol ID
- 401.02.001
- Other IDs
- GCC0121
- Status last verified
- May 2005
- First submitted
- 4 Sep 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00044785
- Acronym / sponsor ID
- 401.02.001
- Conditions
- Solid Tumors
- Keywords
- colorectal cancer, gastric cancer, breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants
- Lead sponsor
- Wellstat TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Mar 2004
- First posted
- 6 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triacetyluridine | Drug | – |
| fluorouracil | Drug | – |
| leucovorin | Drug | – |
| camptosar | Drug | – |
Primary outcome
Safety and Maximum Tolerated Dose
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing triacetyluridine, fluorouracil and leucovorin in people with Solid Tumors, run by Wellstat Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Maximum Tolerated Dose. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.