Combination Chemotherapy Compared With Mitoxantrone in Treating Older Patients With Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

CMF AND MITOXANTRONE IN ELDERLY PATIENTS WITH ADVANCED BREAST CANCER, A RANDOMIZED PHASE II STUDY

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002498
• Other study ID #: CDR0000077804
• Secondary ID: DUT-KWF-CKVO-900
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: December 17, 2013
• Start date: July 1992

Study information

• Verified date: May 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different combinations may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of cyclophosphamide, methotrexate, and fluorouracil with mitoxantrone in treating older patients with recurrent or metastatic breast cancer.

Description:

OBJECTIVES: I. Determine the response rate and duration of response of elderly patients with advanced breast cancer treated with first-line chemotherapy with mitigated "classical" CMF (cyclophosphamide/methotrexate/fluorouracil) vs. mitoxantrone (DHAD). II. Define the morbidity of CMF and DHAD in elderly patients. III. Determine quality of life in these patients.

OUTLINE: This is a randomized study. Patients are stratified by participating institution. The first group receives oral cyclophosphamide on days 1 through 14 and intravenous methotrexate and fluorouracil on days 1 and 8. Courses repeat every 4 weeks for a maximum of 6 courses. The second group receives intravenous mitoxantrone every 3 weeks for a maximum of 8 courses. Concomitant therapy with hepatotoxic or nephrotoxic drugs (e.g., NSAIDs) or corticosteroids (even as antiemetics) is not permitted in either group. Radiotherapy is allowed provided no more than 50% of the bone marrow is irradiated and at least 1 indicator lesion is unirradiated. Patients who complete therapy are followed every 3 months until disease progression.

PROJECTED ACCRUAL: 60 patients will be accrued over approximately 1 year. If extreme differences between arms exist after entry of 30 patients, accrual may be stopped early.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically proven, progressive, recurrent or metastatic breast cancer in patients over 70 years of age Measurable or evaluable disease required, including: Lesions of the mediastinum, retroperitoneum, or liver at least 3 cm in diameter on CT scan or ultrasound The following are not considered measurable or evaluable: Lymphedema Hilar enlargement Pleural effusion Ascites Bone marrow infiltration Osteoblastic skeletal lesion No CNS metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Over 70 Sex: Not specified Menopausal status: Postmenopausal Performance status: WHO 0-2 Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin less than 1.4 mg/dL (25 micromoles/L) Renal: Creatinine clearance (calculated) greater than 50 mL/min in patients weighing at least 45 kg and measured creatinine clearance at least 50 mL/min in patients weighing less than 45 kg Cardiovascular: No congestive heart failure No myocardial infarction within 6 months No severe arrhythmia No complete bundle branch block Other: No active uncontrolled infection No mental disorders that may preclude patient follow-up No second malignancy except: Adequately treated basal cell carcinoma of the skin Adequately treated in situ carcinoma of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced disease At least 1 year since prior adjuvant chemotherapy Endocrine therapy: At least 4 weeks since prior estrogens, androgens, and progestins Tamoxifen or aminoglutethimide allowed with no waiting period if disease progresses Recovery from prior hormonal therapy for metastatic disease required Radiotherapy: Prior radiotherapy allowed provided: Evaluable disease exists outside of treatment field No greater than 50% of bone marrow was irradiated Surgery: Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• CMF regimen

• cyclophosphamide

• fluorouracil

• methotrexate

• mitoxantrone hydrochloride

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden
Netherlands	St. Radboud University Hospital	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands,