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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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.
Given IV
imatinib mesylateDrug
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Gemcitabine Hydrochloride) | Active comparator | Patients receive gemcitabine hydrochloride IV on days 3 and 10. Receives: Drug: gemcitabine hydrochloride |
| Arm II (Gemcitabine Hydrochloride + Imatinib) | Experimental | Patients 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.
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)
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
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.
- First posted9 May 2006 (estimated)
- Study start1 May 2006
- Primary completion15 Apr 2011
- Study completion20 Jun 2016
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Novartis Pharmaceuticals, Rutgers Cancer Institute of New Jersey
- Responsible party
- Principal investigator, Deborah Toppmeyer, MD, Rutgers, The State University of New Jersey
- Investigators
- Deborah R. Toppmeyer, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00323063
- Acronym / sponsor ID
- 0220060081
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IV breast cancer, male breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Novartis Pharmaceuticals, Rutgers Cancer Institute of New Jersey
- Study start
- 1 May 2006 (actual)
- Primary completion
- 15 Apr 2011 (actual)
- Study completion
- 20 Jun 2016 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Posted 29 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Gemcitabine Hydrochloride) | Active comparator | Drug: gemcitabine hydrochloridePatients receive gemcitabine hydrochloride IV on days 3 and 10. |
| Arm II (Gemcitabine Hydrochloride + Imatinib) | Experimental | Drug: gemcitabine hydrochloride, Drug: imatinib mesylatePatients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12. |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| gemcitabine hydrochlorideGiven IV | Drug | Arm I (Gemcitabine Hydrochloride), Arm II (Gemcitabine Hydrochloride + Imatinib) |
| imatinib mesylateGiven orally | Drug | Arm II (Gemcitabine Hydrochloride + Imatinib) |
Primary outcome
Time to Progression
Time frame: 5 years
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).
2 secondary outcomes
Response Rate (Complete and Partial Response)
Time frame: 5 years
Overall Survival
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Deborah R. Toppmeyer, MD principal investigator
Rutgers Cancer Institute of New Jersey
9 sites in 1 country: see every site and its status.
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.