Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
A Phase II Evaluation Of Gleevec (Imatinib Mesylate) (IND #61135, NSC #716051) In The Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. To evaluate the cytostatic, anti-tumor activity of Gleevec (Imatinib Mesylate) through the probability of surviving progression-free for at least 6 months in patients with recurrent or persistent epithelial ovarian or primary peritoneal carcinoma receiving Gleevec.
II. To determine the frequency and severity of adverse effects of Gleevec in this cohort of patients as assessed by CTC.
SECONDARY OBJECTIVES:
I. To determine the distribution of the overall survival. II. To determine the distribution of progression-free survival. III. To estimate the clinical response rate (partial and complete response as defined under the RECIST criteria).
IV. To assess the effects of prognostic variables: initial performance status, platinum sensitivity, and mucinous (or clear cell) histology).
TERTIARY OBJECTIVES:
I. To determine the levels of expression of c-KIT and its ligand, stem cell factor (SCF) in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.
II. To determine the levels of expression of platelet derived growth factor receptor (PDGFR) and its ligand PDGF in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.
III. To determine the levels of expression of AKT2 and its activated form, phospho-AKT2, in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19103
- Gynecologic Oncology Group
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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
Inclusion Criteria:
Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
- Recurrent or persistent disease
At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Tumors within a previously irradiated field considered nontarget lesions
At least one prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for primary disease required
- Initial treatment may include high-dose, consolidation, or extended therapy
- Initial treatment-free interval less than 12 months for patients who received only 1 prior platinum-based regimen
- Initial treatment-free interval of more than 12 months allowed provided disease progression has occurred within 12 months after retreatment with a second-line platinum-based regimen
- Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
- Performance status - GOG 0-2 (if patient has received one prior treatment regimen)
- Performance status - GOG 0-1 (if patient has received two prior treatment regimens)
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT/SGPT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- Creatinine no greater than 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after study participation
- No active infection requiring antibiotics
- No greater than grade 1 sensory and motor neuropathy
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No signs or symptoms of bowel dysfunction
- At least 3 weeks since prior immunologic therapy directed at the malignant tumor
- No concurrent biologic therapy or immunotherapy for the malignant tumor
- Recovered from prior chemotherapy
- No prior noncytotoxic chemotherapy for persistent or recurrent disease
- One additional cytotoxic regimen for persistent or recurrent disease allowed
- No concurrent chemotherapy for the malignant tumor
- At least 1 week since prior hormonal therapy directed at the malignant tumor
- No concurrent therapeutic corticosteroids
- No concurrent anticancer hormonal therapy
- Concurrent hormone replacement therapy allowed
- Recovered from prior radiotherapy
- No prior radiotherapy to more than 25% of marrow-bearing areas
- No concurrent anticancer radiotherapy
- Recovered from recent prior surgery
- At least 3 weeks since other prior therapies directed at the malignant tumor
- No prior imatinib mesylate
- No prior anticancer therapy that would preclude study participation
- No concurrent therapeutic anticoagulation with warfarin
- No other concurrent investigational drugs
- No concurrent amifostine or other protective reagents
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:なし
- 介入モデル:単一グループの割り当て
- 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 |
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実験的:Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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相関研究
与えられたPO
他の名前:
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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 |
---|---|
無増悪生存
時間枠:6ヶ月で
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6ヶ月で
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CTC によって評価された副作用の頻度と重症度
時間枠:最長7年
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最長7年
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二次結果の測定
結果測定 |
時間枠 |
---|---|
無増悪生存期間
時間枠:最長7年
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最長7年
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全生存期間
時間枠:最長7年
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最長7年
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臨床反応の頻度(部分反応と完全反応)
時間枠:最長7年
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最長7年
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Prognostic variables: initial performance status, age, platinum sensitivity, and mucinous (or clear cell) histology
時間枠:Baseline
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Baseline
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (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
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