NCT00004059

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 1999

Typical duration for phase_1

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, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 8, 2003

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

3.2 years

First QC Date

December 10, 1999

Last Update Submit

June 20, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

7-hydroxystaurosporineDRUG
fluorouracilDRUG

Eligibility Criteria

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

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

Interventions

7-hydroxystaurosporineFluorouracil

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 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

May 8, 2003

Study Start

July 1, 1999

Primary Completion

September 1, 2002

Study Completion

September 1, 2002

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

US(1)