Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002498
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Compared With Mitoxantrone in Treating Older Patients With Advanced Breast Cancer
Sponsor:
Leiden University Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
CMF AND MITOXANTRONE IN ELDERLY PATIENTS WITH ADVANCED BREAST CANCER A RANDOMIZED PHASE II STUDY
Status:
UNKNOWN
Status Verified Date:
2000-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 cyclophosphamidemethotrexatefluorouracil 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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-92006 | None | None | None |
| DUT-KWF-CKVO-9008 | None | None | None |