Combination Chemotherapy Compared With Mitoxantrone in Treating Older Patients With Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00002498|
Recruitment Status : Unknown
Verified May 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 23, 2004
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: CMF regimen Drug: cyclophosphamide Drug: fluorouracil Drug: methotrexate Drug: mitoxantrone hydrochloride||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||CMF AND MITOXANTRONE IN ELDERLY PATIENTS WITH ADVANCED BREAST CANCER, A RANDOMIZED PHASE II STUDY|
|Study Start Date :||July 1992|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002498
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 ZA|
|St. Radboud University Hospital|
|Nijmegen, Netherlands, 6500 HB|
|Study Chair:||Marianne A. Nooij, MD||Leiden University Medical Center|