Expired Study
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Cleveland, Ohio 44106


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

CWRU4196


NCT ID:

NCT00006260


Secondary ID:

P30CA043703


Study Acronym:


Brief Title:

Combination Chemotherapy in Treating Patients With Metastatic Breast Cancer


Official Title:

A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Case Comprehensive Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

36


Enrollment Type:

Actual


Overall Contact Information

Official Name:Scot C. Remick, MD
Principal Investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Study Dates

Start Date:May 1997
Primary Completion Date:January 2005
Primary Completion Type:Actual
Verification Date:June 2010
Last Changed Date:June 9, 2010
First Received Date:September 11, 2000

Study Outcomes

Outcome Type:Primary Outcome
Measure: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.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:cisplatin
Description:cisplatin IV over 30 minutes on days 1-3.
Intervention Type:Drug
Name:etoposide
Description:etoposide IV over 60-90 minutes on days 1-3.
Intervention Type:Drug
Name:ifosfamide
Description:ifosfamide IV over 30 minutes on days 1-3.
Intervention Type:Drug
Name:Mesna
Description:Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Case Comprehensive Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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