Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
A Phase II Trial Of IM862 Combined With Paclitaxel And Carboplatin In Newly Diagnosed Advanced Epithelial Ovarian Or Primary Peritoneal Carcinoma Followed By IM862 Consolidation Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and IM-862 may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.
調査の概要
詳細な説明
OBJECTIVES: I. Determine the complete pathologic response rate at second-look surgery in patients with optimally resected stage III ovarian epithelial or primary peritoneal cancer treated with adjuvant paclitaxel, carboplatin, and IM-862. II. Determine the safety profile of this regimen in this patient population. III. Determine the incidence of infectious and hematologic complications in patients treated with this regimen. IV. Determine the progression-free survival of patients with no disease or minimal disease burden after initial therapy, when treated with IM-862 consolidation therapy. V. Correlate angiogenesis markers and immunologic parameters with response in patients treated with this regimen.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of three IM-862 doses. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with IM-862 begins within 10 days of chemotherapy initiation and continues until clinical evidence of disease progression or until 3 days before second-look surgery. Arm I: Patients receive a low-dose of IM-862 and 2 placebo doses intranasally daily. Arm II: Patients receive a medium-dose of IM-862 and 2 placebo doses as in arm I. Arm III: Patients receive higher-dose IM-862 intranasally three times daily. Patients undergo second-look surgery within 4-8 weeks after completion of the last course of chemotherapy. Patients with a complete pathologic response or only microscopically detectable residual disease receive consolidation therapy with IM-862, according to their original treatment arm. Consolidation therapy begins within 3-14 days after second-look surgery and continues for 24 weeks in the absence of disease progression. Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 180 patients (60 per arm) will be accrued for this study within 1 year.
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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California
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Glendale、California、アメリカ、91204
- Comprehensive Cancer Center
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Los Gatos、California、アメリカ、95032
- Community Hospital of Los Gatos
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Stanford、California、アメリカ、94305-5408
- Stanford University Medical Center
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District of Columbia
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Washington、District of Columbia、アメリカ、20007
- Lombardi Cancer Center
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Winship Cancer Institute
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Kansas
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Wichita、Kansas、アメリカ、67214
- University of Kansas School of Medicine-Wichita
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota Cancer Center
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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Nebraska
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Omaha、Nebraska、アメリカ、68198-3330
- University of Nebraska Medical Center
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Nevada
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Las Vegas、Nevada、アメリカ、89030
- Women's Cancer Center - Las Vegas
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New York
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Buffalo、New York、アメリカ、14263-0001
- Roswell Park Cancer Institute
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Taussig Cancer Center
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Columbus、Ohio、アメリカ、43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213-3180
- Magee-Womens Hospital
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Vermont
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Burlington、Vermont、アメリカ、05401
- Fletcher Allen Health Care - Medical Center Campus
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Washington
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Seattle、Washington、アメリカ、98195
- University of Washington School of Medicine
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Seattle、Washington、アメリカ、98109-1024
- Fred Hutchinson Cancer Research Center
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Wisconsin
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Madison、Wisconsin、アメリカ、53792-6164
- University of Wisconsin Comprehensive Cancer Center
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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 III ovarian epithelial cancer or primary peritoneal carcinoma of one of the following cell types: Serous adenocarcinoma Mucinous adenocarcinoma Clear-cell adenocarcinoma Endometrioid Adenocarcinoma (not otherwise specified) Undifferentiated carcinoma Transitional cell Malignant Brenner's tumor Mixed epithelial carcinoma No borderline tumor (tumor of low malignant potential) Underwent prior standard initial cytoreductive surgery within the past 6 weeks Optimally resected disease with no residual site of disease more than 1 cm in greatest dimension Removal of all disease extending beyond the reproductive tract Total hysterectomy and bilateral salpingo-oopherectomy at cytoreductive surgery or in the past
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN SGOT no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast No other major systemic medical illness that would preclude survival No poor general condition or medical, social, or psychosocial factors that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for current malignancy At least 5 years since prior gene therapy At least 1 year since prior interleukin-2 (IL-2) At least 1 year since prior sargramostim (GM-CSF) Concurrent filgrastim (G-CSF) allowed No concurrent gene therapy No concurrent GM-CSF No concurrent IL-2 No other concurrent angiogenesis inhibitors (e.g., thalidomide, cyclooxygenase-2 inhibitors (e.g., rofecoxib or celecoxib), interferon products, or angiotensin-converting enzyme inhibitors) Chemotherapy: At least 5 years since prior anticancer chemotherapy No prior chemotherapy for current malignancy No other concurrent chemotherapy Endocrine therapy: No prior endocrine therapy for current malignancy At least 1 year since prior tamoxifen No concurrent tamoxifen Radiotherapy: No prior radiotherapy for current malignancy Surgery: See Disease Characteristics Other: At least 1 year since prior experimental or investigational medications No other concurrent experimental or investigational medications
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
スポンサー
捜査官
- スタディチェア：Pamela Paley, MD、Pacific Gynecology Specialists
研究記録日
主要日程の研究
研究開始
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
- CDR0000068674
- CYTRAN-IM862-302
- FHCRC-5156
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