- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006260
Combination Chemotherapy in Treating Patients With Metastatic Breast Cancer
A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Drugs such as mesna may be effective in preventing some of the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have metastatic breast cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
- Determine the tolerability and toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to number of prior chemotherapy courses for metastatic disease (0 vs 1).
Patients receive etoposide IV over 60-90 minutes, cisplatin IV over 30 minutes, and ifosfamide IV over 30 minutes on days 1-3. Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months.
PROJECTED ACCRUAL: At least 36 patients (16 per stratum) will be accrued over 36 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106-5055
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically proven progressive metastatic breast cancer
Measurable disease
- Any lesion measurable in 2 dimensions
- Hepatic metastases if the sum of the measurements below the costal margin in the midclavicular line and the tip to the xiphoid process is greater than 5 cm during quiet respiration
- Hepatic defects that are clearly measurable by radionuclide, CAT, or MRI scans
- Bone metastases are not considered measurable disease
- Evaluable disease allowed if measurable disease also present
- No brain metastases, carcinomatous meningitis, or spinal cord compression
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Not specified
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Hemoglobin at least 10 g/dL
- WBC at least 4,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
- No bladder outlet obstruction
Cardiovascular:
- No symptomatic cardiovascular disease (e.g., congestive heart disease) or inability to tolerate a fluid load
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection
- No prior malignancies except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No greater than 1 prior biologic response modifier treatment for metastatic disease
Chemotherapy:
- No greater than 1 prior chemotherapy regimen for metastatic disease allowed
- Patients who relapsed during or within 6 months after adjuvant chemotherapy are considered to have failed 1 regimen
- Patients who relapsed more than 6 months after adjuvant chemotherapy are considered to not have had a prior regimen
- Greater than 4 weeks since prior chemotherapy (greater than 6 weeks for mitomycin or nitrosoureas) and recovered
- No prior cisplatin, etoposide, or ifosfamide
Endocrine therapy:
- Prior medical or surgical hormonal therapy allowed
Radiotherapy:
- Prior radiation therapy to areas of measurable disease allowed if indicator lesion increased in size by greater than 25% after treatment
- Recovered from effects of prior radiotherapy
Surgery:
- Recovered from effects of major surgery
Other:
- At least 7 days since prior nephrotoxic drugs (e.g., aminoglycosides, diuretics, lithium, intravenous contrast, or nonsteroidal antiinflammatory drugs)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
Time Frame: Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
|
Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Etoposide
- Ifosfamide
Other Study ID Numbers
- CWRU4196
- P30CA043703 (U.S. NIH Grant/Contract)
- CWRU-4196
- BMS-CRWU-4196
- NCI-G00-1854
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
Ohio State University Comprehensive Cancer CenterCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Stage III Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast CancerUnited States
Clinical Trials on cisplatin
-
West China Second University HospitalRecruitingNeoadjuvant Chemotherapy | Epithelial Carcinoma, OvarianChina
-
Privo TechnologiesNational Cancer Institute (NCI)CompletedOral Squamous Cell CarcinomaUnited States
-
Cedars-Sinai Medical CenterRecruitingHPV Positive Oropharyngeal Squamous Cell CarcinomaUnited States
-
Korea Cancer Center HospitalCompletedCervical CancersKorea, Republic of
-
Insmed IncorporatedCompletedOsteosarcoma MetastaticUnited States
-
Sun Yat-sen UniversityActive, not recruitingNasopharyngeal CarcinomaChina
-
Samsung Medical CenterUnknownNasophayngeal Carcinoma Between Stage II and IVbKorea, Republic of
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial People... and other collaboratorsActive, not recruitingNasopharyngeal Carcinoma | Nasopharyngeal Neoplasms | Nasopharyngeal Diseases | Head and Neck NeoplasmChina
-
Lawson Health Research InstituteRecruitingLocally Advanced Head and Neck Squamous Cell CarcinomaCanada
-
Fujian Cancer HospitalNot yet recruitingNasopharyngeal CarcinomaChina