Ovarian Cancer Clinical Trial
Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Full Description
OBJECTIVES:
Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy.
Determine the safety of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral topotecan twice daily for 21 days. Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression.
Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses. The maximum tolerated dose is defined as the dose tolerated by the majority of the patients.
Patients are followed every 2 months for at least 6 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal serous cancer
Stage IIIB, IIIC, or IV
Surgically staged and debulked
Complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria:
No evidence of cancer by history or physical examination
CA 125 no greater than 35 units/mL
No evidence of residual cancer on CT scan of the abdomen/pelvis and chest x-ray
Must have received at least 5 courses of first-line chemotherapy
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-2
Life expectancy
Not specified
Hematopoietic
Granulocyte count at least 1,200/mm^3
Platelet count at least 90,000/mm^3
Hepatic
Bilirubin normal
ALT and AST less than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase less than 1.5 ULN
Renal
Creatinine clearance at least 60 mL/min
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent immunotherapy
Chemotherapy
See Disease Characteristics
At least 3 weeks since prior first-line chemotherapy
At least 3 years since other prior chemotherapy (other than first-line chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer)
No other concurrent chemotherapy
Endocrine therapy
No concurrent hormonal therapy
Radiotherapy
No prior abdominopelvic radiotherapy
No concurrent radiotherapy
Surgery
See Disease Characteristics
No concurrent surgery
Other
No other concurrent antitumor therapy
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There is 1 Location for this study
Boston Massachusetts, 02215, United States
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