Topotecan, High-Dose Cyclophosphamide, Carboplatin, and an Autologous Peripheral Blood Cell Transplant in Treating Patients With Recurrent Ovarian Cancer or Primary Peritoneal Cancer
A Dose Seeking Trial of Topotecan Combined With High-Dose Cyclophosphamide and Carboplatin With Peripheral Blood Stem Cell Transplant for the Treatment of Relapsed Ovarian Cancer and Primary Peritoneal Cancer
RATIONALE: Giving colony-stimulating factors, such as G-CSF help stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Combination chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This randomized trial is studying the side effects and best dose of topotecan when given together with high-dose cyclophosphamide, and carboplatin followed by an autologous peripheral blood stem cell transplant in treating patients with recurrent ovarian cancer or primary peritoneal cancer.
調査の概要
詳細な説明
OBJECTIVES:
- To determine the maximum tolerated dose of topotecan hydrochloride combined with high-dose cyclophosphamide and carboplatin in the setting of autologous peripheral blood stem cell transplantation for relapsed, recurrent, or persistent ovarian epithelial or primary peritoneal cavity cancer.
- To assess the toxicity of this regimen.
OUTLINE: This is a dose escalation study of topotecan.
- Autologous hematopoietic stem cell collection: Patients receive filgrastim subcutaneously (SC) daily for 5 days. Patients undergo leukapheresis per standard practice until a minimum of 2 x10^6 CD34+ cells/kg are collected and cryopreserved.
- High-dose chemotherapy: Patients receive topotecan hydrochloride IV, cyclophosphamide IV, and carboplatin IV over 8 hours on days -6 to -3.
- Autologous peripheral stem cell reinfusion: Patients undergo autologous peripheral blood stem cell transplantation on day 0. Patients also receive sargramostim SC daily beginning on day 5 and continuing until blood counts recover.
After completion of study therapy, patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 5 years.
研究の種類
入学 (予想される)
段階
- フェーズ 1
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 or primary peritoneal cavity cancer
Recurrent, relapsed, or persistent disease meeting 1 or more of the following criteria:
- Patients with a positive second-look laparotomy who are not candidates for higher priority GOG protocols
- Largest mass of recurrent disease ≤ 0.2 cm achieved by surgery or chemotherapy
- Achievement of complete response to 1 prior regimen of platinum-based chemotherapy with relapse > 6 months from last chemotherapy
- Achievement of partial response to 1 platinum-based chemotherapy regimen prior to study
- Histological proof of disease recurrence with or without a rising serum CA-125 level (relapsed or recurrent disease)
The following histological cell types are allowed:
- Clear-cell adenocarcinoma
- Endometrioid adenocarcinoma
- Mixed epithelial carcinoma
- Mucinous adenocarcinoma
- Serous adenocarcinoma
- Undifferentiated carcinoma
- Must have unilateral bone marrow aspirate and biopsy with cytogenetics without evidence of metastatic ovarian carcinoma by conventional morphology within 1 month of registration
- Not eligible for GOG-164
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Creatinine ≤ 1.5 mg/dL
- Total bilirubin ≤ 2.0 mg/dL (≤ 5.0 mg/dL with metastatic disease)
- AST ≤ 2 times upper limit of normal (ULN) (≤ 600 units/mL with metastatic disease)
- Alkaline phosphatase ≤ 2 times ULN (unless related to metastatic disease)
- ANC ≥ 1,000/mm^3
- Platelets ≥ 100,000/mm^3
- Cardiac ejection fraction ≥ 45% by rest ECHO or MUGA
- FEV_1 ≥ 50% of predicted
- HIV negative
- No uncontrolled infection
No severe medical or psychiatric illness, including any of the following:
- Renal failure
- Brittle insulin dependent diabetes mellitus
- Congestive heart failure
- History of myocardial infarction within the past 3 months
- Significant arrhythmia requiring medication
- Poorly controlled hypertension (diastolic blood pressure >100 mm Hg)
- History of hospitalization for severe depression or psychosis
- Significant non-neoplastic pulmonary disease
- Current alcohol or drug abuse.
- Active infection
- Active peptic ulcer disease
- No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 1 prior treatment regimen for this cancer
- More than 3 weeks since surgery
- No prior topotecan hydrochloride
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
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
---|
Maximum tolerated dose of topotecan hydrochloride
|
Toxicity according to NCI criteria
|
協力者と研究者
スポンサー
捜査官
- スタディチェア:Mark R. Litzow, MD、Mayo Clinic
- 主任研究者:Lawrence A Solberg, M.D.、Mayo Clinic
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
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 (実際)
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
- 976101 (その他の識別子:Mayo Clinic Cancer Center)
- P30CA015083 (米国 NIH グラント/契約)
- 1056-98 (その他の識別子:Mayo Clinic IRB)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。
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