Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
A Phase III Study of Cisplatin Plus Topotecan Followed by Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Women With Newly Diagnosed Advanced Epithelial Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Compare the efficacy of cisplatin and topotecan followed by paclitaxel and carboplatin vs paclitaxel and carboplatin only, in terms of time to disease progression, in patients with newly diagnosed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.
- Compare the overall survival of patients treated with these regimens.
- Compare the clinical objective response rates in patients with measurable disease at baseline treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the CA 125 normalization rates in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (65 years and under vs over 65 years), and pre-randomization surgery (no debulking vs debulking with macroscopic residual disease less than 1 cm vs debulking with macroscopic residual disease 1 cm or greater vs debulking with no macroscopic residual disease). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive cisplatin IV over 60 minutes on day 1 and topotecan IV over 30 minutes on days 1-5 of courses 1-4 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 5-8.
- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 1-8.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Planned interval debulking surgery should occur after course 3 or 4.
Quality of life is assessed at baseline; on day 1 of courses 3, 5, and 7; at the end of the last course; and at 3 and 6 months after study treatment completion.
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 2 years.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
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Alberta
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Calgary、Alberta、カナダ、T2N 4N2
- Tom Baker Cancer Centre
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Edmonton、Alberta、カナダ、T6G 1Z2
- Cross Cancer Institute
-
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British Columbia
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Kelowna、British Columbia、カナダ、V1Y 5L3
- BCCA - Cancer Centre for the Southern Interior
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North Vancouver、British Columbia、カナダ、V7L 2L7
- Lions Gate Hospital
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Surrey、British Columbia、カナダ、V3V 1Z2
- BCCA - Fraser Valley Cancer Centre
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Vancouver、British Columbia、カナダ、V5Z 4E6
- BCCA - Vancouver Cancer Centre
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Manitoba
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Winnipeg、Manitoba、カナダ、R3E 0V9
- CancerCare Manitoba
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-
New Brunswick
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Moncton、New Brunswick、カナダ、E1C 6Z8
- The Moncton Hospital
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Saint John、New Brunswick、カナダ、E2L 4L2
- Atlantic Health Sciences Corporation
-
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Newfoundland and Labrador
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St. John's、Newfoundland and Labrador、カナダ、AIB 3V6
- Dr. H. Bliss Murphy Cancer Centre
-
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3H 1V7
- QEII Health Sciences Center
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Ontario
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Hamilton、Ontario、カナダ、L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
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Kingston、Ontario、カナダ、K7L 5P9
- Cancer Centre of Southeastern Ontario at Kingston
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Kitchener、Ontario、カナダ、N2G 1G3
- Grand River Regional Cancer Centre
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London、Ontario、カナダ、N6A 4L6
- London Regional Cancer Program
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Ottawa、Ontario、カナダ、K1H 8L6
- Ottawa Health Research Institute - General Division
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St. Catharines、Ontario、カナダ、L2R 7C6
- Niagara Health System
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Sudbury、Ontario、カナダ、P3E 5J1
- Northeast Cancer Center Health Sciences
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Thunder Bay、Ontario、カナダ、P7B 6V4
- Thunder Bay Regional Health Science Centre
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Toronto、Ontario、カナダ、M5G 2M9
- Univ. Health Network-Princess Margaret Hospital
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Windsor、Ontario、カナダ、N8W 2X3
- Windsor Regional Cancer Centre
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Prince Edward Island
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Charlottetown、Prince Edward Island、カナダ、C1A 8T5
- PEI Cancer Treatment Centre,Queen Elizabeth Hospital
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Quebec
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Montreal、Quebec、カナダ、H4J 1C5
- Hôpital du Sacré-Cœur de Montréal
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Montreal、Quebec、カナダ、H2L 4M1
- CHUM - Hopital Notre-Dame
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Quebec City、Quebec、カナダ、G1R 2J6
- CHUQ-Pavillon Hotel-Dieu de Quebec
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Sherbrooke、Quebec、カナダ、J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke
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Saskatchewan
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Regina、Saskatchewan、カナダ、S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon、Saskatchewan、カナダ、S7N 4H4
- Saskatoon Cancer Centre
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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 stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer
- No borderline ovarian tumors
- Residual disease allowed
Fine needle aspiration showing an adenocarcinoma is allowed instead of open or true-cut biopsy if the following are true:
- Presence of pelvic mass AND
- Omental cake or other metastasis larger than 2 cm in the upper abdomen unless proven stage IV disease AND
- Serum CA 125/carcinoembryonic antigen ratio at least 25 (if less than 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for primary tumor within 6 weeks of study) AND
- Normal mammography within 6 weeks of study
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- ECOG 0-1
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Granulocyte count at least 2,000/mm^3
- Platelet count at least 150,000/mm^3
Hepatic:
- Not specified
Renal:
- Creatinine no greater than upper limit of normal
Cardiovascular:
- No clinically relevant atrial or ventricular arrhythmias
- No myocardial infarction (MI) within the past 6 months (pretreatment ECG as only evidence of MI allowed)
- No history of second- or third-degree heart blocks unless pacemaker implanted
- History of first-degree heart block allowed
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No complete bowel obstruction
- No prior allergic reaction to drugs containing Cremophor EL or compounds chemically related to study drugs
- No condition that would preclude high-volume saline diuresis
- No significant neurologic or psychiatric disorder that would preclude study compliance
- No active uncontrolled infection
- No neuropathy greater than grade 1
- No pre-existing hearing loss greater than grade 1
- No other concurrent serious illness or medical condition that would preclude study participation
- No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biological response modifiers or immunotherapy
No concurrent prophylactic colony-stimulating factors (CSFs)
- Concurrent therapeutic CSFs allowed
Chemotherapy:
- No prior chemotherapy for ovarian cancer
- No other concurrent cytotoxic agents
Endocrine therapy:
- No concurrent anticancer hormonal therapy
Radiotherapy:
- No prior radiotherapy for ovarian cancer
Surgery:
- No more than 6 weeks since prior planned pre-chemotherapy surgery for ovarian cancer
- Planned interval debulking allowed
- Concurrent second-look surgery allowed
Other:
- No prior non-surgical therapy for ovarian cancer
- No other concurrent investigational drug therapy
- No other concurrent anticancer treatment
- Concurrent enrollment on CAN-NCIC-OV13/EORTC 55971 allowed
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:なし(オープンラベル)
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:Cisplatin, Topotecan, Paclitaxel plus Carboplatin
Arm 1
|
Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle
4 cycles 50mg/m2 (60 mins) day 1 of 21 day cycle
Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle
4 cycles .75mg/m2 (30 mins) days 1-5 of 21 day cycle |
アクティブコンパレータ:Paclitaxel plus Carboplatin
Arm 2
|
Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle
Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle
|
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 |
時間枠 |
---|---|
Progression free survival
時間枠:Mar 2008
|
Mar 2008
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
全生存
時間枠:2012 年 12 月
|
2012 年 12 月
|
Response Rates
時間枠:March 2008
|
March 2008
|
Toxic Effects
時間枠:March 2008
|
March 2008
|
Quality of Life
時間枠:March 2008
|
March 2008
|
CA125 Normalization Rates
時間枠:March 2008
|
March 2008
|
協力者と研究者
協力者
捜査官
- スタディチェア:Paul J. Hoskins, MD、British Columbia Cancer Agency
出版物と役立つリンク
一般刊行物
- Hoskins PJ, Vergote I, Stuart G, et al.: A phase III trial of cisplatin plus topotecan followed by paclitaxel plus carboplatin versus standard carboplatin plus paclitaxel as first-line chemotherapy in women with newly diagnosed advanced epithelial ovarian cancer (EOC) (OV.16). A Gynecologic Cancer Intergroup Study of the NCIC CTG, EORTC GCG, and GEICO. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5505, 2008.
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
- OV16
- CAN-NCIC-OV16 (その他の識別子:PDQ)
- EORTC-55012 (その他の識別子:EORTC)
- GEICO-0101 (その他の識別子:GEICO)
- CDR0000069129 (その他の識別子:PDQ)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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
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
carboplatinの臨床試験
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)引きこもったステージ IIIA 非小細胞肺がん | ステージ IIIB 非小細胞肺がん | 扁平上皮肺がん | 肺の腺癌 | 大細胞肺がん | ステージ IIA 非小細胞肺がん | ステージ IIB 非小細胞肺がん
-
Children's Oncology GroupNational Cancer Institute (NCI)完了脳腫瘍 | 中枢神経系腫瘍アメリカ, カナダ, オーストラリア, スイス, オランダ, ニュージーランド