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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.


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Maximum Tolerated Dose

Authority:

United States: Food and Drug Administration

Study ID:

401.02.001

NCT ID:

NCT00044785

Start Date:

August 2002

Completion Date:

March 2004

Related Keywords:

  • Solid Tumors
  • colorectal cancer
  • gastric cancer
  • breast cancer
  • Neoplasms

Name

Location

University of Maryland, Greenebaum Cancer CenterBaltimore, Maryland  21201