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
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, randomized study. Patients are randomized to 1 of 2 treatment arms.
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.
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 →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.
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Disease progression after at least 1 prior chemotherapy regimen for metastatic disease
No known symptomatic or untreated brain metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
No uncontrolled illness, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 3 weeks since prior radiotherapy
No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin® or Coumadine®)
Patients receive gemcitabine hydrochloride IV on days 3 and 10.
Drug: gemcitabine hydrochloride
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
Given IV
Given orally
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
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
Overall Survival
Time frame: 5 years
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.
| Milestone | Gemcitabine Hydrochloride | Gemcitabine Hydrochloride + Imatinib |
|---|---|---|
| Started | 26 | 23 |
| Completed | 24 | 23 |
| Not completed | 2 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Brain mets discovered prior to treatment | 1 | 0 |
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).
| months | Arm I (Gemcitabine Hydrochloride) | Arm II (Gemcitabine Hydrochloride + Imatinib) |
|---|---|---|
| Time to Progression | 2 (1 to 5) | 2.5 (1 to 5) |
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
| percentage of participants | Arm 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) |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 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%) |
| Event | Arm I (Gemcitabine Hydrochloride) | Arm II (Gemcitabine Hydrochloride + Imatinib) |
|---|---|---|
| DehydrationMetabolism and nutrition disorders | 2/26 | 2/23 |
| VomitingGastrointestinal disorders | 2/26 | 1/23 |
| FeverGeneral disorders | 2/26 | 0/23 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/26 | 1/23 |
| Neutrophils decreasedInvestigations | 0/26 | 1/23 |
| AnemiaInvestigations | 0/26 | 1/23 |
| Lung InfectionInfections and infestations | 0/26 | 1/23 |
| Event | Arm I (Gemcitabine Hydrochloride) | Arm II (Gemcitabine Hydrochloride + Imatinib) |
|---|---|---|
| Neutrophil count decreasedInvestigations | 20/26 | 10/23 |
| White blood cell decreasedInvestigations | 14/26 | 7/23 |
| AnemiaBlood and lymphatic system disorders | 13/26 | 8/23 |
| FatigueGeneral disorders | 10/26 | 4/23 |
| AlopeciaSkin and subcutaneous tissue disorders | 8/26 | 8/23 |
| NauseaGastrointestinal disorders | 9/26 | 5/23 |
| Platelet count decreasedInvestigations | 7/26 | 5/23 |
| VomitingGastrointestinal disorders | 5/26 | 3/23 |
| FeverGeneral disorders | 5/26 | 1/23 |
| Alanine aminotransferaseInvestigations | 4/26 | 1/23 |
Study was prematurely closed due to slow accrual.
| Age, Categorical(Participants) | Arm I | Arm II | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 13 | 28 |
| >=65 years | 11 | 10 | 21 |
| Age, Continuous(years) | Arm I | Arm II | Total |
|---|---|---|---|
| Median | 60.7 (39 to 78) | 62.4 (45 to 81) | 61.5 (39 to 81) |
| Sex: Female, Male(Participants) | Arm I | Arm II | Total |
|---|---|---|---|
| Female | 26 | 23 | 49 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Arm I | Arm II | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 24 | 22 | 46 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm I | Arm II | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 6 | 13 |
| White | 17 | 16 | 33 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm I | Arm II | Total |
|---|---|---|---|
| United States | 26 | 23 | 49 |
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Rutgers, The State University of New Jersey