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Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004059
First Posted: May 8, 2003
Last Update Posted: June 21, 2013
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: 7-hydroxystaurosporine Drug: fluorouracil Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: July 1999
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00004059


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Gary K. Schwartz, MD Memorial Sloan Kettering Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00004059     History of Changes
Other Study ID Numbers: 99-024
CDR0000067256 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-T99-0037
First Submitted: December 10, 1999
First Posted: May 8, 2003
Last Update Posted: June 21, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Fluorouracil
7-hydroxystaurosporine
Staurosporine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors