Pemetrexed-Carboplatin and Gemcitabine-Vinorelbine in Advanced Breast Cancer
2011年4月26日 更新者：Eli Lilly and Company
A Randomized Phase II Study of Two Chemotherapy Regimens, Pemetrexed-Carboplatin, and Gemcitabine-Vinorelbine, in Anthracycline and Taxanes Pretreated Advanced Breast Cancer Patients
The primary purpose of this study is to help answer the following research questions:
- whether the chemotherapy combination therapy Pemetrexed-Carboplatin or Gemcitabine-Vinorelbine can help participants with advanced breast cancer to make the tumor smaller or disappear and for how long
- to learn more about the side effects in each chemotherapy combination treatment arm
- to assess how participants with advanced breast cancer report health changes while receiving any of the chemotherapy combination arm
調査の概要
研究の種類
介入
入学 (実際)
135
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Bergamo、イタリア、24128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bologna、イタリア、40139
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Livorno、イタリア、57128
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Meldola、イタリア、47014
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Rome、イタリア、00168
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San Giovanni Rotondo、イタリア、71013
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Barcelona、スペイン、08036
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Girona、スペイン、17007
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La Coruña、スペイン、15006
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Lleida、スペイン、25198
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Madrid、スペイン、28040
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Valencia、スペイン、46010
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Zaragoza、スペイン、50009
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Guetersloh、ドイツ、33332
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Hamburg、ドイツ、22081
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Stuttgart、ドイツ、70190
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Besevler/Ankara、七面鳥、06500
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Bornova、七面鳥、35100
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Kayseri、七面鳥、38039
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Durban、南アフリカ、4067
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Morningside、南アフリカ、2199
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pretoria、南アフリカ、0001
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- Females with histologic or cytologic diagnosis of advanced breast cancer. Lesions should not be amenable to surgery or radiation of curative intent.
- Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale.
- One prior chemotherapy containing anthracyclines as (neo)adjuvant or palliative 1st-line treatment.
- One prior chemotherapy containing taxanes as (neo) adjuvant or palliative 1st-line treatment.
- Prior radiation therapy is allowed to less than 25% of the bone marrow. Participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. 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.
- At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Positron emission tomography [PET] scans and ultrasounds may not be used.
- Antitumoral hormonal treatment must be discontinued prior to enrollment.
- Estimated life expectancy of at least 3 months.
- Participant compliance and geographic proximity that allow adequate follow-up.
- Adequate organ function
- Female participants of childbearing potential must test negative for pregnancy within 7 days of enrollment based on a urine and/or serum pregnancy test and agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
- Participants must sign an informed consent document.
- Female participants must be at least 18 years of age.
Exclusion Criteria:
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Have previously completed or withdrawn from this study or any other study investigating Pemetrexed, Gemcitabine, Carboplatin or Vinorelbine
- Have received more than one line of chemotherapy in Metastatic Breast Cancer. Participants having received more than one combination of anthracycline plus taxane.
- Are pregnant or breast-feeding.
- Have serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to complete the study.
- Have a prior malignancy other than breast cancer, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
- Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam), unless the Creatinine Clearance is greater than or equal to 80 ml/min.
- Have central nervous system (CNS) metastases.
- Have clinically relevant (by physical exam) third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry.
- Are unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.
- Concurrent administration of any other antitumor therapy.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
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実験的：Pemetrexed/Carboplatin
Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC (Area under the plasma drug concentration versus time curve) 5.0 mg*min/mL. The cycle of treatment was 21 days. |
600 mg/m^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity.
他の名前：
AUC 5 mg*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity.
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アクティブコンパレータ：Gemcitabine/Vinorelbine
Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion.
The cycle of treatment was 21 days.
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1200 mg/m^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
他の名前：
30 mg/m^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
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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 |
メジャーの説明 |
時間枠 |
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Tumor Response Rate
時間枠：Baseline up to 30 days of follow-up after 21 cycles of treatment
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Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria.
For CR or PR, best response must be confirmed.
A second assessment performed at 28 days.
Two determinations of CR before progression required for rate to=CR.
Evaluations include: CR=Disappearance of lesions.
PR=≥30% size decrease of lesions.
Progressive Disease (PD)=≥20% size increase of lesions.
Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD.
Overall Response Rate=PR+CR/Qualified Participants*100.
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Baseline up to 30 days of follow-up after 21 cycles of treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Duration of Response (DOR)
時間枠：Time of response to progressive disease (up to 19 months)
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DOR-RECIST criteria of (Complete Response [CR =Disappearance of lesions] or Partial Response [PR=≥30% size decrease of lesions]) is defined as time from the date when measurement criteria are met for CR or PR until the date of first observation of progressive disease (PD) or death from study disease.
For participants who die from causes other than study disease and without PD, DOR will be censored at the date of death.
For participants who have not died as of the data cut-off date who are without PD, DOR was censored at last contact date.
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Time of response to progressive disease (up to 19 months)
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Time to Progressive Disease (PD)
時間枠：Baseline to measured PD (up to 25.1 months)
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Time to PD is defined as the time from the date of study enrollment to the first documented date of PD or death from study disease.
For participants who die from causes other than study disease and without PD, time to PD was censored at the date of death.
For participants not known to have died as of the data cut-off date and do not have PD, time to PD was censored at the last contact date.
For participants who received subsequent chemotherapy (after discontinuation from the study chemotherapy) prior to disease progression, time to PD was censored at the date of subsequent chemotherapy.
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Baseline to measured PD (up to 25.1 months)
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Time To Treatment Failure (TTTF)
時間枠：Baseline to end of treatment (up to 21.9 months)
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TTTF is defined as the time from date of study enrollment to the first documented date of death, PD, or study treatment discontinuation due to adverse event (AE).
For participants not known to have discontinued as of the data cut-off date, TTTF is censored at the last contact date.
For participants who discontinued for reasons other than death, PD, or AE, TTTF is censored at the date of discontinuation.
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Baseline to end of treatment (up to 21.9 months)
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Time to Response
時間枠：Baseline to response (up to 7.8 months)
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Time to response (Complete Response(CR) or Partial Response (PR) is defined as the time from the date of study enrollment to the first date when the measurement criteria are met for complete response or partial response (whichever status is recorded first).
CR=Disappearance of target lesions lesions.
PR=≥30% size decrease of lesions.
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Baseline to response (up to 7.8 months)
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Number of Participants With Adverse Events (AE)
時間枠：every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)
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A listing of adverse events is presented in the Reported Adverse Event Module.
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every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2006年6月1日
一次修了 (実際)
2010年4月1日
研究の完了 (実際)
2010年8月1日
試験登録日
最初に提出
2006年5月10日
QC基準を満たした最初の提出物
2006年5月10日
最初の投稿 (見積もり)
2006年5月12日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年5月20日
QC基準を満たした最後の更新が送信されました
2011年4月26日
最終確認日
2011年4月1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。
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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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
Pemetrexedの臨床試験
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Instituto Nacional de Cancer, BrazilEli Lilly and Company完了