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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00084513

Trastuzumab and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic HER2/Neu-Expressing Cancer

A Phase 1 study testing trastuzumab and imatinib mesylate in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Fox Chase Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
trastuzumab and imatinib mesylate
How many people
18 participants
Where
1 siteUnited States
Study dates
Aug 2004to Mar 2007
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 or cytologically confirmed cancer that overexpresses HER2/neu, measured 3+ by immunohistochemistry or positive by fluorescence in situ hybridization
  • Recurrent or metastatic disease
  • Meets 1 of the following criteria for measurable or evaluable disease:
  • Unidimensionally measurable disease at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Evaluable disease, defined as a lesion on physical examination or imaging study that can be assessed as to changes in size but cannot be clearly measured in 1 dimension (e.g., pleural effusions, ascites, or bone disease)
  • No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease
  • Prior controlled brain parenchymal disease allowed provided at least 8 weeks since prior therapy AND no symptomatic progression off corticosteroids

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • ALT and AST ≤ 2.0 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.0 times ULN
  • Bilirubin ≤ 1.3 mg/dL
  • No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)

Renal

  • Creatinine ≤ 2.0 mg/dL

Cardiovascular

  • Ejection fraction ≥ lower limit of normal by MUGA
  • No uncontrolled or significant cardiovascular disease
  • No myocardial infarction within the past 6 months
  • No ischemic heart disease requiring medication
  • No congestive heart failure

Pulmonary

  • No uncontrolled or significant pulmonary disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • No active unresolved infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior trastuzumab (Herceptin®) allowed
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) to support blood counts
  • No other concurrent anticancer biologic agents

Chemotherapy

  • Prior chemotherapy for metastatic disease allowed
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • More than 2 weeks since prior major surgery

Other

  • At least 7 days since prior antibiotics
  • No concurrent parenteral antibiotics
  • No other concurrent anticancer agents
  • No other concurrent investigational drugs
  • No concurrent therapeutic anticoagulation with warfarin
  • Concurrent mini-dose warfarin (1 mg/day) for prophylaxis of central venous catheter thrombosis allowed

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

Official title: Phase I of Trastuzumab and Imatinib Mesylate (Gleevec®, Formerly Known as STI-571) in Patients With Recurrent or Metastatic Her-2/Neu Expressing Cancer

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Giving trastuzumab together with imatinib mesylate 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 trastuzumab in treating patients with recurrent or metastatic HER2/neu-expressing (producing) cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of imatinib mesylate when administered with trastuzumab (Herceptin®) in patients with recurrent or metastatic HER2/neu-overexpressing cancer.
  • Determine response in patients treated with this regimen.

Secondary

  • Correlate the number of circulating tumor cells with radiographic imaging in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of imatinib mesylate.

Patients receive trastuzumab (Herceptin®) IV over 90 minutes on day 1 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 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 9-18 patients will be accrued for this study.

Being tested
trastuzumab, 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of imatinib mesylate given concurrently with trastuzumab (Herceptin®) as measured by CTC v 3.0 at course 1

  2. Response as measured by RECIST criteria every 9 weeks

Secondary outcomes (2)
  1. Circulating tumor cells in blood as measured by Immunicom Cell PrepTM at baseline, every 3 weeks until week 9, and then with each disease re-evaluation

  2. Phosphorylation status of AKT, extracellular signal-regulated kinase (ERK), and KIT as measured by western blot and/or immunohistochemistry at baseline and week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2004 (estimated)
  2. Study startAug 2004
  3. Study completionMar 2007

Resources

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
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00084513
Sponsor's protocol ID
CDR0000365451
Other IDs
P30CA006927, FCCC-03041, NOVARTIS-FCCC-03041
Status last verified
Feb 2010
First submitted
10 Jun 2004
Last updated
12 Feb 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing trastuzumab and imatinib mesylate in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Fox Chase Cancer Center 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 12 Feb 2010. 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.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of imatinib mesylate given concurrently with trastuzumab (Herceptin®) as measured by CTC v 3.0 at course 1. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Feb 2010.

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