- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00055614
Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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-
Massachusetts
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Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Stephen A. Cannistra, MD, Beth Israel Deaconess Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BIDMC-E-010405FB
- CDR0000269138 (레지스트리 식별자: PDQ (Physician Data Query))
- NEDH-E-010405FB
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