Stage IV Breast Cancer Clinical Trial
Official title:
Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules in Women With Advanced Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Antineoplastons are naturally occurring substances that may
also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. It
is not yet known whether giving antineoplastons with chemotherapy is more effective than
chemotherapy alone in treating women with refractory breast cancer.
PURPOSE: This randomized phase II trial is studying methotrexate alone to see how well it
works campared to methotrexate and antineoplaston therapy in treating postmenopausal women
with advanced refractory breast cancer.
OBJECTIVES:
- Compare the antitumor activity of antineoplaston A10 with methotrexate vs methotrexate
alone, in terms of objective tumor response, in women with advanced breast cancer.
- Compare the adverse effects of and tolerance to these regimens in these patients.
OUTLINE: This is a randomized study.
- Arm I: Patients receive gradually escalating doses of oral antineoplaston A10 capsules
7 times daily until the maximum tolerated dose is reached, followed by oral
methotrexate capsules 2 to 3 times per day in five days on and five days off courses.
Treatment continues in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral methotrexate alone on the same schedule as in arm I.
Tumors are measured every 4 months for 2 years, every 6 months for years 3 and 4, and then
annually for years 5 and 6.
PROJECTED ACCRUAL: A total of 30-70 patients will be accrued for this study within at least
12 months.
;
Primary Purpose: Treatment
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