Full Text View
Tabular View
No Study Results Posted
Related Studies
Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
This study has been completed.
Study NCT00004059   Information provided by National Cancer Institute (NCI)
First Received: December 10, 1999   Last Updated: July 23, 2008   History of Changes

December 10, 1999
July 23, 2008
July 1999
 
 
 
Complete list of historical versions of study NCT00004059 on ClinicalTrials.gov Archive Site
 
 
 
Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
A Phase I Study of the Cyclin-Dependent Kinase (CDK)/Protein Kinase C (PKC) Inhibitor UCN-01 (NSC 638850) in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.

PURPOSE: Phase I trial to study the effectiveness of fluorouracil plus UCN-01 in treating patients who have advanced or refractory solid tumors.

OBJECTIVES:

  • Determine the maximum tolerated dose, dose limiting toxicity, and toxicity profile of fluorouracil with UCN-01 in patients with advanced or refractory solid tumors.
  • Assess the clinical pharmacokinetics of this regimen and correlate with observed toxicities in these patients.
  • Obtain preliminary data on the therapeutic activity of this regimen in these patients.

OUTLINE: This is a dose escalation study of fluorouracil.

Patients receive fluorouracil IV over 24 hours on days 1, 8, 15, and 22. Patients receive an initial dose of UCN-01 IV over 72 hours beginning on day 2 during course 1 and then maintenance UCN-01 IV over 36 hours beginning on day 2 during subsequent courses. Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of fluorouracil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 6-48 patients will be accrued for this study within approximately 14 months.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: 7-hydroxystaurosporine
  • Drug: fluorouracil
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
  • Measurable or evaluable disease
  • No CNS metastasis or primary CNS malignancy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 3,500/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT and SGPT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • No history of coronary artery disease documented by prior myocardial infarction, angiography, or coronary-artery bypass grafting
  • No cardiac arrhythmias or congestive heart failure within the past 6 months
  • Stable atrial fibrillation on standard treatment allowed at discretion of investigator

Pulmonary:

  • DLCO at least 60% of predicted

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study
  • No active serious or uncontrolled infection
  • HIV negative
  • No diabetes
  • No other medical condition that would preclude study

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
  • Prior fluorouracil allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior mediastinal radiotherapy
  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • No concurrent anticonvulsant medications
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004059
 
CDR0000067256, MSKCC-9924, NCI-T99-0037
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Gary K. Schwartz, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP