Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00253565
Imatinib Mesylate and Capecitabine in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing capecitabine and imatinib mesylate in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Herbert Hurwitz at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- capecitabine and imatinib mesylate
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
About this study
Official title: A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies
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.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of imatinib mesylate when administered with capecitabine in patients with advanced malignant solid tumors.
Secondary
- Determine the non-dose-limiting toxic effects of this regimen in these patients.
- Determine, preliminarily, the clinical activity of this regimen in these patients.
- Determine the pharmacokinetics and pharmacogenetics of this regimen in these patients.
- Determine, preliminarily, the effect of this regimen on wound angiogenesis in these patients.
- Correlate pharmacokinetic parameters with clinical toxicity, clinical activity, or surrogate biomarker activity of this regimen in these patients.
OUTLINE: This is a dose escalation study of imatinib mesylate.
Patients receive oral capecitabine twice daily on days 1-14 and oral imatinib mesylate once or twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of imatinib mesylate until the maximum tolerated dose is determined.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
- Being tested
- capecitabine, imatinib mesylate
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
imatinib mesylateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startAug 2003
- Primary completionJul 2006
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herbert Hurwitz
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Herbert Hurwitz, Duke University
- Investigators
- Herbert I. Hurwitz, MD, Study chair, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253565
- Sponsor's protocol ID
- Pro00009521
- Other IDs
- DUMC-3992-05-8R3, ROCHE-DUMC-3992-05-8R3, NOVARTIS-DUMC-3992-05-8R3, CDR0000448905
- Status last verified
- Apr 2013
- First submitted
- 11 Nov 2005
- Last updated
- 8 Apr 2013
- Results posted
- No
Publications
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.
PubMed 20530436
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT00253565
- Acronym / sponsor ID
- Pro00009521
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Herbert HurwitzUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of imatinib mesylate when administered with capecitabine in patients with advanced malignant solid tumors.
Secondary
- Determine the non-dose-limiting toxic effects of this regimen in these patients.
- Determine, preliminarily, the clinical activity of this regimen in these patients.
- Determine the pharmacokinetics and pharmacogenetics of this regimen in these patients.
- Determine, preliminarily, the effect of this regimen on wound angiogenesis in these patients.
- Correlate pharmacokinetic parameters with clinical toxicity, clinical activity, or surrogate biomarker activity of this regimen in these patients.
OUTLINE: This is a dose escalation study of imatinib mesylate.
Patients receive oral capecitabine twice daily on days 1-14 and oral imatinib mesylate once or twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of imatinib mesylate until the maximum tolerated dose is determined.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine | Drug | – |
| imatinib mesylate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
- Results publication: PubMed 20530436Dugan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert I. Hurwitz, MD study chair
Duke Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing capecitabine and imatinib mesylate in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Herbert Hurwitz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00253565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2013.