Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)
Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX)
調査の概要
詳細な説明
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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New York
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New York、New York、アメリカ、10032
- Columbia University Medical 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
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of pancreas metastatic to liver and/or lungs or peritoneal surface. (a.k.a. Stage IV B).
- No prior chemotherapy with Gemzar, Xeloda and Taxotere.
- Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by x-ray, physical examination, CT or MRI scans.
The following lesions conventionally are not considered measurable:
- CNS lesions
- Blastic or lytic bone lesions (which should be documented and followed)
- Radiated lesions unless progression after RT is documented
- Ineligible for other high priority national or institutional studies
Prior radiation and surgery allowed:
- > 3 weeks since surgery
- > 4 weeks since RT
- Non pregnant females who are not breast feeding with a negative serum or urine β-HCG test within 1 week of starting the study. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
Clinical Parameters:
- Life expectancy > 2 months
- Age 18 - 70 years old
- Performance status 0-2 (ECOG)
- Peripheral Neuropathy must be < grade 1
- Able to tolerate oral medications
Required initial laboratory data:
- Absolute Neutrophil Count > 1,500 μl
- White Blood Count > 3,000/μl
- Platelet count > 100,000/μl
- BUN < 1.5 x normal
- Creatinine < 1.5 normal
- Hemoglobin > 8.0 g/dl
- Serum Albumin > 3 mg/dl
- Total Bilirubin < 2.0 mg/dl
- SGOT, SGPT, Alkaline Phosphatase SGOT and SGPT may be up to 3.0 x ULN if Alk Phos < 2.0 x ULN; or Alk Phos may be up to 3.0 x ULN if SGOT and SGPT are < 2.0 x ULN
Exclusion Criteria:
- Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.
- Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
- The patient has not had a prior malignancy in last 5 years other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer
- No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
- Patients with brain metastases are excluded.
- Patients known to have HIV will be excluded.
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 |
---|---|
実験的:Gemzar, Taxotere, Xeloda
Gemcitabine, Docetaxel, Capecitabine: Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days |
1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11 This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.
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 |
メジャーの説明 |
時間枠 |
---|---|---|
To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer
時間枠:10 weeks
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Data was not analyzed because original PI left institution before data analysis was completed.
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10 weeks
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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 |
---|---|---|
Determine Overall and One Year Survival Rates
時間枠:One year
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Data was not analyzed because original PI left institution before data analysis was completed.
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One year
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Toxicity Assessment
時間枠:Every month
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Data was not analyzed because original PI left institution before data analysis was completed.
|
Every month
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協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始
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 (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。
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