NCT00006260

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1997

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Last Updated

June 11, 2010

Status Verified

June 1, 2010

Enrollment Period

7.7 years

First QC Date

September 11, 2000

Last Update Submit

June 9, 2010

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

  • Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.

    Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.

Interventions

cisplatinDRUG

cisplatin IV over 30 minutes on days 1-3.

etoposideDRUG

etoposide IV over 60-90 minutes on days 1-3.

ifosfamideDRUG

ifosfamide IV over 30 minutes on days 1-3.

MesnaDRUG

Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5055, United States

Location

Related Publications (1)

  • Viana LV, Leitao CB, Grillo MF, Rocha EP, Brenner JK, Friedman R, Gross JL. Hypertension management algorithm for type 2 diabetic patients applied in primary care. Diabetol Metab Syndr. 2013 Sep 12;5(1):52. doi: 10.1186/1758-5996-5-52.

    PMID: 24028306DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CisplatinEtoposideIfosfamideMesna

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicSulfhydryl CompoundsSulfur CompoundsSulfonic AcidsSulfur Acids

Study Officials

  • Scot C. Remick, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

May 1, 1997

Primary Completion

January 1, 2005

Last Updated

June 11, 2010

Record last verified: 2010-06

Locations

US(1)