Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting
A Phase IV Study Comparing the Efficacy of Fosaprepitant to Aprepitant for Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecological Cancer
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
California
-
Newport Beach、California、アメリカ、92663
- Gynecologic Oncology Associates
-
-
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
Inclusion Criteria:
- Female Gender
- Age > 18 years
- A histologic diagnosis of stage III/IV gynecologic cancer (e.g., epithelial ovarian, fallopian tube, peritoneal cancer and uterine cancer).
- Subjects who will be treated with Taxol and Carboplatin as standard of care for a newly diagnosed gynecological cancer.
- Adequate bone marrow function as demonstrated by:
Absolute neutrophil count (ANC) > 1,500/μL; platelet count > 100,000/μL; and hemoglobin > 9 g/dL • Adequate renal function demonstrated by: Serum creatinine of < 1.5 x ULN or 24-hr measured urine creatinine clearance > 60 mL/min for patients with serum creatinine > 1.5 x ULN
• Adequate hepatic function demonstrated by: Total bilirubin of < 1.5 x ULN AST or ALT ≤ 2.5 x ULN
- EGOG status of < 2: Postoperatively, patients demonstrate an ECOG score of 1 or 2. However, during the first cycle of chemotherapy, the patients' performance status improves to < 1.
- Projected life expectancy of at least 3 months
- Ability to comply with the visit schedule and assessments required by the protocol
- Negative pregnancy test for women of childbearing potential
- Signed, IRB approved informed consent and HIPPA consent
Exclusion Criteria:
- Subjects with a diagnosis of epithelial ovarian, fallopian tube or peritoneal cancers of low malignant potential (borderline carcinomas) are not eligible.
- Allergy or intolerance to 5HT3 or NK-1 antagonists and dexamethasone
- An episode of vomiting or retching within 24 hours before the start of the initial treatment with chemotherapy
- Subjects with concomitant malignancy or a previous malignancy within the past three (3) years (except non-melanoma skin cancer)
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
- Screening clinical laboratory values of:
ANC of <1500/DL Platelet count of <100,000/µL Total bilirubin of *1.5 mg/dL x ULN SGOT (AST) or SGPT (ALT) * 2.5 x ULN Serum creatinine of * 1.5 mg/dL Hemoglobin of * 9 gm/dL (may be transfused or receive a colony stimulating factor to maintain or exceed this level)
- EGOG status of > 2
- Gastrointestinal obstruction or an active peptic ulcer
- Patients who are pregnant or breast feeding because aprepitant may be harmful to the developing fetus and newborn
- Known active HIV and viral hepatitis infections
- Inability to comply with study
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D)
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
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Fosaprepitant
Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.
Oral Placebo given on days 1-3
|
Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.
Patient will receive standard pre-medications
他の名前:
One pill administered on days 1-3 in conjunction with Fosaprepitant.
|
アクティブコンパレータ:Aprepitant
Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. 100 cc of IV placebo administered on day 1
|
Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications
他の名前:
100 cc of IV placebo administered on day in conjunction with Aprepitant
他の名前:
|
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 |
メジャーの説明 |
時間枠 |
---|---|---|
Overall Complete Response Rate
時間枠:13 months
|
no emetic episodes or rescue therapy following the initiation of chemotherapy
|
13 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Impact on Daily Living Activities
時間枠:13 months
|
Proportion of patients reporting no impact on daily living activities following initiation of chemotherapy
|
13 months
|
協力者と研究者
捜査官
- 主任研究者:John P Micha, MD、Gynecologic Oncology Associates
研究記録日
主要日程の研究
研究開始
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
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。
卵巣がんの臨床試験
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
fosaprepitantの臨床試験
-
Merck Sharp & Dohme LLC完了化学療法による吐き気と嘔吐(CINV)