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TerminatedNCT00323063Updated Mar 29, 2023Results posted

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

A Phase 2 interventional study of gemcitabine hydrochloride and imatinib mesylate in Breast Cancer, sponsored by Rutgers, The State University of New Jersey. Terminated at 9 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by Rutgers, The State University of New Jersey · Phase 2, Interventional, and Treatment

Why this study was terminated
Slow accrual
Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • recurrent breast cancer
  • stage IV breast cancer
  • male breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 49 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Active comparator
    Arm I (Gemcitabine Hydrochloride)

    Patients receive gemcitabine hydrochloride IV on days 3 and 10.

    Drug: gemcitabine hydrochloride

  • Experimental
    Arm II (Gemcitabine Hydrochloride + Imatinib)

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

    Drug: gemcitabine hydrochloride · Drug: imatinib mesylate

Interventions

  • Druggemcitabine hydrochloride

    Given IV

  • Drugimatinib mesylate

    Given orally

06

What researchers measure

Primary outcomes

  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).

    Time frame: 5 years

Secondary outcomes

  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

    Time frame: 5 years

  2. Overall Survival

    Time frame: 5 years

07

Results

Posted Nov 29, 2017
Limitations and caveats
This study was underpowered to draw any conclusion regarding a difference in TTP between the two groups at the time is was prematurely closed.

Participant flow

This study was opened to accural on 5/1/2006 and was closed to accrual on 4/15/2011 due to slow accrual. Subjects were recruited through the Cancer Institute of New Jersey Oncology Group. We are reporting results on 49 eligible patients. One was not eligible for participation.

Participant flow — Overall Study
MilestoneGemcitabine HydrochlorideGemcitabine Hydrochloride + Imatinib
Started2623
Completed2423
Not completed20
Withdrew: Adverse event10
Withdrew: Brain mets discovered prior to treatment10

Outcome measures

PrimaryTime 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).

Time frame:
5 years
Reported as:
Median · months
Time to Progression
monthsArm I (Gemcitabine Hydrochloride)Arm II (Gemcitabine Hydrochloride + Imatinib)
Time to Progression2 (1 to 5)2.5 (1 to 5)
Statistical analysis
  • Arm I (Gemcitabine Hydrochloride) vs Arm II (Gemcitabine Hydrochloride + Imatinib) · Log Rank · p = 0.3
SecondaryResponse 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

Time frame:
5 years
Reported as:
Number · percentage of participants
Response Rate (Complete and Partial Response)
percentage of participantsArm I (Gemcitabine Hydrochloride)Arm II (Gemcitabine Hydrochloride + Imatinib)
Response Rate (Complete and Partial Response)9.1 (1.6 to 30.6)9.1 (1.6 to 30.6)
SecondaryOverall Survival
Time frame:
5 years

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (Gemcitabine Hydrochloride)0/26 (0%)5/26 (19.2%)26/26 (100%)
Arm II (Gemcitabine Hydrochloride + Imatinib)2/23 (8.7%)6/23 (26.1%)23/23 (100%)
Most frequent serious events
Most frequent serious events
EventArm I (Gemcitabine Hydrochloride)Arm II (Gemcitabine Hydrochloride + Imatinib)
DehydrationMetabolism and nutrition disorders2/262/23
VomitingGastrointestinal disorders2/261/23
FeverGeneral disorders2/260/23
DyspneaRespiratory, thoracic and mediastinal disorders0/261/23
Neutrophils decreasedInvestigations0/261/23
AnemiaInvestigations0/261/23
Lung InfectionInfections and infestations0/261/23
Most frequent other events
Showing 10 of 29
Most frequent other events
EventArm I (Gemcitabine Hydrochloride)Arm II (Gemcitabine Hydrochloride + Imatinib)
Neutrophil count decreasedInvestigations20/2610/23
White blood cell decreasedInvestigations14/267/23
AnemiaBlood and lymphatic system disorders13/268/23
FatigueGeneral disorders10/264/23
AlopeciaSkin and subcutaneous tissue disorders8/268/23
NauseaGastrointestinal disorders9/265/23
Platelet count decreasedInvestigations7/265/23
VomitingGastrointestinal disorders5/263/23
FeverGeneral disorders5/261/23
Alanine aminotransferaseInvestigations4/261/23

Baseline characteristics

Study was prematurely closed due to slow accrual.

Age, Categorical
Age, Categorical(Participants)Arm IArm IITotal
<=18 years000
Between 18 and 65 years151328
>=65 years111021
Age, Continuous
Age, Continuous(years)Arm IArm IITotal
Median60.7 (39 to 78)62.4 (45 to 81)61.5 (39 to 81)
Sex: Female, Male
Sex: Female, Male(Participants)Arm IArm IITotal
Female262349
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm IArm IITotal
Hispanic or Latino213
Not Hispanic or Latino242246
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm IArm IITotal
American Indian or Alaska Native000
Asian213
Native Hawaiian or Other Pacific Islander000
Black or African American7613
White171633
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Arm IArm IITotal
United States262349
08

Study locations

9 sites
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    Chicago, Illinois 60611-3013, United States
  • University of Maryland Greenebaum Cancer Center
    Baltimore, Maryland 21201, United States
  • Cooper Hospital/University Medical Center
    Camden, New Jersey 08103, United States
  • Rutgers Cancer Institute of New Jersey at Hamilton
    Hamilton, New Jersey 08690, United States
  • Mountainside Hospital
    Montclair, New Jersey 07042, United States
  • Jersey Shore Cancer Center at Jersey Shore University Medical Center
    Neptune, New Jersey 07754, United States
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey 08903, United States
  • Saint Peter's University Hospital
    New Brunswick, New Jersey 08903, United States
  • NJ Medical School
    Newark, New Jersey 07103, United States
09

References and documents

Study documents

  • Informed consent form · Dec 4, 2009

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00323063
Lead sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Novartis Pharmaceuticals, Rutgers Cancer Institute of New Jersey
Responsible party
Deborah Toppmeyer, MD (Chief, Division of Medical Oncology, Rutgers, The State University of New Jersey) — Principal investigator
First posted
May 9, 2006
Start date
May 1, 2006
Primary completion
Apr 15, 2011
Completion
Jun 20, 2016
Results posted
Nov 29, 2017
Last update
Mar 29, 2023

Study contacts

Deborah R. Toppmeyer, MD
principal investigator · Rutgers Cancer Institute of New Jersey

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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