NCT00045747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_2 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

June 24, 2013

Status Verified

August 1, 2004

First QC Date

September 6, 2002

Last Update Submit

June 21, 2013

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreasrecurrent pancreatic cancerstage IV pancreatic cancer

Interventions

7-hydroxystaurosporineDRUG
fluorouracilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

7-hydroxystaurosporineFluorouracil

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gary K. Schwartz, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

July 1, 2002

Study Completion

September 1, 2004

Last Updated

June 24, 2013

Record last verified: 2004-08

Locations

US(1)