Gemcitabine Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines and/or Taxanes
Randomized Phase II Study of the Combination of Gemcitabine (Gemzar) Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines an/or Taxanes
This is an open label, two arms, randomized, unblinded phase 2 study in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline with/without taxane based regimen in the adjuvant/neoadjuvant or 1st line metastatic setting. Gemcitabine will be administered via intravenous infusion over approximately 30 minutes at a dose of 1250mg/m2 on days 1 and 8 of each 21-day cycle. In arm A:Cisplatin will be given via intravenous infusion over approximately 60-120 minutes at a dose of 70 mg/m2 on Day 1 of each 21-day cycle. The investigator may attempt to give Cisplatin with at least one liter of fluids for hydration and on an outpatient basis.
Patients will remain in the study until disease progression or when a maximum of six cycles have been administered. Study therapy may continue until:
- There is evidence of progressive disease
- The patient experiences unacceptable toxicity.
- The investigator decides that the patient should be discontinued.
- The patient requests discontinuation
- The patient has received 6 cycles of the regimen (if the physician decides to continue after 6 cycles-this will be done after consultation with the sponsor)
- Discontinuation from study therapy is indicated according to the additional guidelines described in the protocol After patients discontinue from study therapy, they proceed to the post-study follow up phase of the study.
調査の概要
研究の種類
入学
段階
- フェーズ2
連絡先と場所
研究場所
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Jeddah、サウジアラビア
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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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:
- Histological or cytological diagnosis of breast carcinoma with evidence of unresectable, locally recurrent, or metastatic disease. Lesions should not be amenable to surgery or radiation of curative intent.
- Presence of metastatic or local-regional recurrent disease, according to the American Joint Committee on Cancer
- Uni-dimensionally measurable lesions with clearly defined margin that are clearly measurable by following methods according to computerized tomography (CT), Chest x-ray or clinical examination, according to RECIST criteria
- Patients with unresectable, locally recurrent or metastatic breast cancer who, were pre-treated with anthracyclines with/without taxanes (paclitaxel, docetaxel)containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study. Prior chemotherapy has to be terminated 4 weeks prior. Study randomization and disease progression under this therapy has to be documented, also patients must have completely recovered from all acute chemotherapy related toxicities (with exception of alopecia).
Prior radiotherapy must be completed at least 30 days before study entry. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment (except for alopecia). Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
Exclusion Criteria:
- Have received treatment within the last 30 days with an investigational drug for any indication before study entry.
- Concurrent administration of other tumor therapy, including cytotoxic chemotherapy, surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including Herceptin)
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy, unless adequately treated.
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment(except in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin)
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)
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 |
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Overall response rates of the combination of gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline with/without taxane based regimen
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in the adjuvant/neoadjuvant or 1st line metastatic setting for each treatment arm separately.
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二次結果の測定
結果測定 |
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To characterize the quantitative and qualitative toxicity of gemcitabine-cisplatin patient population for each treatment arm separately;Relative dose intensity of gemcitabine and cisplatin for each treatment arm separately
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Rate of dose modifications (omissions, reductions, delays) for each treatment arm separately;Time to progression for each treatment arm separately;Duration of response for each treatment arm separately;1-year survival in each treatment arm separately
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Overall survival in each treatment arm separately;To assess the medical resources utilization with the combination in each treatment arm separately
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
研究の完了
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
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。
転移性乳がんの臨床試験
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Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者完了
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