NCT00253565

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with capecitabine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with capecitabine in treating patients with advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2003

Longer than P75 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

August 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

2.9 years

First QC Date

November 11, 2005

Last Update Submit

April 4, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

capecitabineDRUG
imatinib mesylateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignant solid tumors for which no standard effective therapy exists OR such therapy is refused * Previously treated brain metastases that are currently asymptomatic allowed PATIENT CHARACTERISTICS: Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 2,000/mm\^3 * Platelet count \> 100,000 mm\^3 * Hemoglobin \> 9.0 g/dL Hepatic * Alkaline phosphatase \< 2.5 times upper limit of normal (ULN) * SGOT and SGPT \< 2.5 times ULN * Bilirubin \< 1.5 times ULN Renal * Creatinine clearance \> 50 mL/min Cardiovascular * No congestive heart failure * No symptomatic coronary artery disease * No uncontrolled cardiac arrhythmias * No myocardial infarction within the past 12 months * No other clinically significant cardiac disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No prior unanticipated severe reaction to fluoropyrimidine therapy * No known sensitivity to fluorouracil PRIOR CONCURRENT THERAPY: Biologic therapy * More than 28 days since prior biologic therapy Chemotherapy * More than 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin C) Endocrine therapy * At least 90 days since prior steroids for the treatment of brain metastases * More than 28 days since prior hormonal therapy Radiotherapy * At least 90 days since prior radiotherapy for the treatment of brain metastases * More than 28 days since other prior radiotherapy * No prior pelvic radiotherapy \> 30% of the bone marrow Surgery * More than 28 days since prior surgery and recovered

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

Sponsors & Collaborators

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Dugan E, Truax R, Meadows KL, Nixon AB, Petros WP, Favaro J, Fernando NH, Morse MA, Blobe GC, Hurwitz HI. A phase I dose-escalation study of imatinib mesylate (Gleevec/STI571) plus capecitabine (Xeloda) in advanced solid tumors. Anticancer Res. 2010 Apr;30(4):1251-6.

    PMID: 20530436RESULT

MeSH Terms

Interventions

CapecitabineImatinib Mesylate

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesBenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazines

Study Officials

  • Herbert I. Hurwitz, MD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

August 1, 2003

Primary Completion

July 1, 2006

Study Completion

July 1, 2010

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations

US(1)