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


Phase 2
N/A
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CWRU4196

NCT ID:

NCT00006260

Start Date:

May 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065