search
Back to results

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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
7-hydroxystaurosporine
fluorouracil
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 OR Karnofsky 70-100% Life expectancy More than 8 weeks Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac tachyarrhythmia Pulmonary No symptomatic chronic obstructive pulmonary disease No pulmonary embolism within the past 6 months Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy 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 Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior radiotherapy and recovered No prior mediastinal irradiation No concurrent radiotherapy Surgery Not specified Other 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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
June 21, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00045747
Brief Title
UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
Official Title
Phase II Study of UCN-01 in Combination With Fluorouracil in Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
7-hydroxystaurosporine
Intervention Type
Drug
Intervention Name(s)
fluorouracil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 OR Karnofsky 70-100% Life expectancy More than 8 weeks Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac tachyarrhythmia Pulmonary No symptomatic chronic obstructive pulmonary disease No pulmonary embolism within the past 6 months Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy 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 Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior radiotherapy and recovered No prior mediastinal irradiation No concurrent radiotherapy Surgery Not specified Other 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary K. Schwartz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs