Oral Topotecan, Utilization for a Metronomic Dosing Schedule to Treat Recurrent or Persistent Solid Tumors
- Patient provides written informed consent prior to study-specific screening
procedures, with the understanding that the patient has the right to withdraw from
the study at any time, without prejudice.
- Male or female patients.
- Patient is at least 18 years of age with recurrent or persistent solid tumors.
- Patient has adequate hematologic function (absolute neutrophil count [ANC] >= 1500/mL
and platelets >= 100,000/mL), adequate renal function (serum creatinine < 2.0 mg/dL;
calculated creatinine clearance > 40 mL/min), and adequate hepatic function (serum
bilirubin <= 1.5 mg/dL and transaminases <= 3 times the upper limit of normal [3 x
- Patient has Eastern Oncology Cooperative Group (ECOG) performance status of <= 2.
- Patient has a life expectancy of at least 3 months at time of enrollment.
- Patient has no medical problems, unrelated to the malignancy, of sufficient severity
which would limit full compliance with the study or which would expose him/her to
- Patient has received no more than 2 prior treatment regimens prior to enrollment
including chemotherapy, hormonal therapy, biologic therapy, and immunotherapy.
- Patient has a negative serum or urine pregnancy test within 7 days prior to starting
therapy (if a female of childbearing potential).
- Patient is a pregnant or lactating woman. Women of childbearing potential with
either a positive or no pregnant test (serum or urine) at baseline. Women of
childbearing potential not using a reliable and appropriate contraceptive method will
be excluded. (Postmenopausal women must have been amenorrheic for at least 12 months
to be considered of non-childbearing potential.) Patients must agree to continue
contraception for 30 days from the date of the last study drug administration.
- Patient has serious, uncontrolled, concurrent infection(s).
- Patient has received whole pelvic or extended field radiation therapy within 4 weeks
of enrollment. Patients who have not fully recovered or whose acute toxicity related
to prior radiotherapy has not returned to baseline are ineligible.
- Patient has received myelosuppressive chemotherapy within the last 4 weeks or has not
recovered from the myelosuppressive effects of recent chemotherapy.
- Patient has received another investigational agent within 4 weeks prior to study
- Patient has known hypersensitivity to topoisomerase I inhibitors.
- Patient is unable to swallow a capsule or has a disease known to affect drug
absorption, such as short gut syndrome or active radiation enteritis.
- Patient has received drugs known to alter absorption such as antacids, proton pump
blockers (eg, omeprazole), or H2 receptor antagonists (eg, cimetidine). A washout
period of one week (7 days) is required prior to initiating study medication.