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Breast CancerPhase 2NCT00323063

Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast Cancer

A Phase 2 study testing gemcitabine hydrochloride and imatinib mesylate in people with Breast Cancer, run by Rutgers, The State University of New Jersey at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Breast Cancer
What is being tested?
gemcitabine hydrochloride and imatinib mesylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
9 sitesUnited States
Study dates
1 May 2006to 20 Jun 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer
  • Locally advanced or metastatic disease
  • Disease progression after at least 1 prior chemotherapy regimen for metastatic disease
  • No more than 2 prior chemotherapy regimens for metastatic disease (prior neoadjuvant or adjuvant treatment will not be included in determining the number of prior chemotherapy regimens)
  • Measurable disease
  • No known symptomatic or untreated brain metastases or carcinomatous meningitis
  • Previously treated and clinically stable brain metastases allowed provided patient has been off steroids for > 7 days
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Male or female
  • Menopausal status not specified
  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study therapy
  • Able to swallow oral medication
  • No coexisting medical condition that would preclude study compliance
  • No uncontrolled illness, including any of the following:
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia requiring therapy
  • Myocardial infarction within the past 6 months
  • Active infection
  • No New York Heart Association class III-IV cardiac disease
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine hydrochloride and/or imatinib mesylate
  • No other primary malignancies within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
  • No known HIV infection

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • More than 2 weeks since prior surgery
  • At least 2 weeks since prior hormonal therapy
  • At least 2 weeks since prior trastuzumab (Herceptin®)
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • At least 3 weeks since prior anti-vascular endothelial growth factor therapy
  • More than 28 days since prior investigational agents
  • At least 3 weeks since prior radiotherapy
  • Must have evidence of ≥ 1 measurable target lesion outside the irradiated fields OR radiologically confirmed disease progression within the irradiated fields after completion of radiotherapy
  • No prior imatinib mesylate for metastatic disease
  • No prior gemcitabine hydrochloride for metastatic disease
  • More than 6 months since prior adjuvant gemcitabine hydrochloride
  • No other concurrent investigational or commercial agents
  • No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin® or Coumadine®)
  • Concurrent heparin or low-molecular weight heparin (e.g., Lovenox®) for therapeutic anticoagulation allowed
  • Concurrent prophylactic warfarin therapy (e.g., mini-dose Coumadin® ≤ 1 mg daily) to maintain catheter patency allowed
  • No concurrent routine chronic systemic corticosteroids
  • No concurrent medications that would preclude study compliance

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites
  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Cooper Hospital/University Medical Center

    Camden, New Jersey, 08103

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Rutgers Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Mountainside Hospital

    Montclair, New Jersey, 07042

  • Jersey Shore Cancer Center at Jersey Shore University Medical Center

    Neptune City, New Jersey, 07754

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08903

  • NJ Medical School

    Newark, New Jersey, 07103

Other trials in United States

About this study

Official title: Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate Versus Gemcitabine Alone in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see how well they work compared to gemcitabine alone in treating patients with previously treated locally advanced or metastatic breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare time to progression in patients with previously treated locally advanced or metastatic breast cancer treated with gemcitabine hydrochloride with vs without imatinib mesylate.

Secondary

  • Compare the efficacy of these regimens in these patients.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the safety and tolerability of these regimens in these patients.

OUTLINE: This is a multicenter, open-label, randomized study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV on days 3 and 10.
  • Arm II: Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.

In both arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Conditions
Breast Cancer
Being tested
gemcitabine hydrochloride, imatinib mesylate
Keywords
recurrent breast cancer, stage IV breast cancer, male breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Medical subject headings
Breast Neoplasms, Breast Neoplasms, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00323063
Study groupRoleWhat they receive
Arm I (Gemcitabine Hydrochloride)Active comparatorPatients receive gemcitabine hydrochloride IV on days 3 and 10.
Receives: Drug: gemcitabine hydrochloride
Arm II (Gemcitabine Hydrochloride + Imatinib)ExperimentalPatients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.
Receives: Drug: gemcitabine hydrochloride; Drug: imatinib mesylate

What is being measured

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

  1. Time to Progression

    Sample size of 40 patients per group was needed to detect an 8 month increase in time to progression with the combination (80% power, alpha =.05, 2-sided).

    Measured: 5 years

Secondary outcomes (2)
  1. Response Rate (Complete and Partial Response)

    Overall response rate was evaluated every 2 cycles (six weeks) for both groups using international criteria by the Response Evaluation Criteria in Solid Tumors (RECISTv1.0) for target lesions and were assessed by CT or MRI. Response rates were defined as complete response (CR), disappearance of all target lesions; partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response(OR) defined as OR=CR + PR

    Measured: 5 years

  2. Overall Survival

    Measured: 5 years

Timeline

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

  1. First posted9 May 2006 (estimated)
  2. Study start1 May 2006
  3. Primary completion15 Apr 2011
  4. Study completion20 Jun 2016

Why it stopped: Slow accrual

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00323063
Sponsor's protocol ID
0220060081
Other IDs
P30CA072720, CDR0000539445, 0220060081, NJ1105, NCI-2012-00520, 040504
Status last verified
Mar 2023
First submitted
8 May 2006
Last updated
29 Mar 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride and imatinib mesylate in people with Breast Cancer, run by Rutgers, The State University of New Jersey at 9 sites 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: stopped early, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Progression (time frame: 5 years). 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 29 Mar 2023.

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