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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
協力者と研究者
捜査官
- スタディチェア:Stephen A. Cannistra, MD、Beth Israel Deaconess Medical Center
研究記録日
主要日程の研究
研究開始
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BIDMC-E-010405FB
- CDR0000269138 (レジストリ識別子:PDQ (Physician Data Query))
- NEDH-E-010405FB
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。