NCT00002498

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	CMF regimen
DRUG	cyclophosphamide
DRUG	fluorouracil
DRUG	methotrexate
DRUG	mitoxantrone hydrochloride

Timeline

• Start date: 1992-07-01
• First posted: 2004-08-23
• Last updated: 2013-12-18

Locations

2 sites across 1 country: Netherlands