Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Stephen A. Cannistra, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Beth Israel Deaconess Medical Center
Authority:
United States: Federal Government
Study ID:
BIDMC-E-010405FB
NCT ID:
NCT00055614
Start Date:
May 2002
Completion Date:
October 2007
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- fallopian tube cancer
- primary peritoneal cavity cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
