Clinical trial · Interventional
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
NCT00006260CI-TRIAL-00003564completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
- timeFrame
- Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDViana 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 24028306