UCN-01 And Fluorouracil In Treating Patients With Metastatic Pancreatic Cancer

Study Overview

UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer

RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with fluorouracil in treating patients who have metastatic pancreatic cancer that has not responded to treatment with gemcitabine.

OBJECTIVES: * Determine the response rate, time to progression, and overall survival of patients with gemcitabine-refractory metastatic pancreatic cancer treated with UCN-01 and fluorouracil. * Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1, 8, 15, and 22. Patients also receive UCN-01 IV continuously over 72 hours (course 1 only) beginning on day 2. In subsequent courses, UCN-01 is infused over 36 hours. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 3-13 months.

Pancreatic Cancer

DRUG: 7-hydroxystaurosporine
DRUG: fluorouracil

CDR0000257125
MSKCC-02049
NCI-5509

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2002-09-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-06-21
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-06-24
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2004-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed adenocarcinoma of the pancreas

Progressive disease after gemcitabine-based chemotherapy for metastatic disease
At least 1 unidimensionally measurable metastatic lesion

At least 20 mm by conventional techniques OR
At least 10 mm by spiral CT scan
Primary disease site is not considered a measurable lesion
No known brain metastases

18 and over

ECOG 0-1 OR
Karnofsky 70-100%

More than 8 weeks

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

Bilirubin normal
AST/ALT no greater than 2.5 times upper limit of normal

Creatinine normal OR
Creatinine clearance at least 60 mL/min

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac tachyarrhythmia

No symptomatic chronic obstructive pulmonary disease
No pulmonary embolism within the past 6 months

No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01 or other agents used in this study
No diabetes mellitus uncontrolled by insulin or oral hypoglycemic agents
No uncontrolled concurrent illness
No ongoing or active infection
No psychiatric illness or social situation that would preclude study
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception before, during, and for 3 months after study

No concurrent immunotherapy

See Disease Characteristics
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
No more than 1 prior chemotherapy regimen for metastatic or recurrent disease
No prior fluorouracil in the adjuvant or inoperable, locally advanced setting (except as a radiosensitizer)
No other concurrent chemotherapy

Not specified

More than 4 weeks since prior radiotherapy and recovered
No prior mediastinal irradiation
No concurrent radiotherapy

Not specified

No prior UCN-01 or other cyclin-dependent kinase inhibitors
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent investigational or commercial anticancer agents or therapies
No concurrent anticonvulsant medications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Gary K. Schwartz, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record