Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer
Phase II Study of Patients With Hormone-Naïve Prostate Cancer With a Rising Prostate Specific Antigen: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Thalidomide Plus Docetaxel
調査の概要
詳細な説明
As more men are being diagnosed and treated for prostate cancer at an early age, the number who experiences a rising level of prostate-specific antigen (PSA) after initial treatment is increasing, affecting approximately 50,000 patients each year.
These three drugs are commercially available. Thalidomide is an angiogenesis inhibitor which blocks the development of new blood vessels. GM-CSF stimulates the body's immune response to fight cancer. Docetaxel is the most active chemotherapeutic agent in the treatment of prostate cancer. GM-CSF and thalidomide have proven activity in suppressing PSA values.
This study design offers an opportunity to add cytotoxic therapy (docetaxel) in combination with an active pathobiologic regimen (GM-CSF plus thalidomide) to eradicate micrometastatic disease, thus potentially offering a significant delay to clinical failure as measured by a rise in PSA or radiographic involvement. Additionally, delays in the use of hormone therapy has the potential to be of significant benefit.
GM-CSF will be administered at a fixed dose 3 days per week by subcutaneous injection for 12 months. Participants will receive a fixed dose of thalidomide orally at bedtime daily without interruption for 12 months. Docetaxel will be administered intravenously over 1 hour on week 1 of every cycle (every 3 weeks) for 18 weeks.
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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Texas
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Houston、Texas、アメリカ、77030
- The Methodist Hospital Research Institute
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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:
- Diagnosis of adenocarcinoma of the prostate.
- Failure of local treatments (surgery and/or radiation) as defined by a rising PSA; demonstrated by at least three consecutive rises in PSA by intervals of at least 4 weeks apart with an absolute change of at least 1 ng/mL. If the confirmatory PSA (third PSA) is less than the previous screening PSA value, an additional test for rising PSA will be required to document progression.
- No clinical or radiographic evidence of disease.
- The Zubrod performance status 0-1.
- Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as long as androgen therapy has been completed at least 1 year prior to study entry.
- Adequate hematologic function: absolute granulocytes ≥ 1500/ul, platelets ≥ 100,000/ul, hemoglobin ≥ 10 gm/100 ml within 4 weeks prior to study entry.
- Adequate hepatic function: bilirubin ≤ 1.5 mg/dl, liver enzymes ≤ 1.5 ULN within 4 weeks prior to study entry.
- Adequate renal function: creatinine ≤ 1.5 x ULN within 4 weeks prior to study entry.
- Patients treated with bisphosphonate therapy before or after study entry are eligible to continue in the study.
- Negative bone scan within 6 weeks prior to study entry.
- Negative CT scan or MRI of the abdomen and pelvis within 6 weeks prior to study entry.
- Negative chest x-ray for metastatic disease within 6 weeks prior to study entry.
- Patients must sign a written informed consent prior to treatment.
Exclusion Criteria:
- Serious intercurrent medical illness including symptomatic heart disease within 6 months.
- Previous or concurrent invasive cancers other than superficial non-melanomatous skin cancer unless disease-free for at least 5 years.
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- History of thromboembolic events (deep venous thrombosis, symptomatic cerebrovascular events or pulmonary embolism), history of MI, within the last 12 months.
- History of bleeding disorders that would contraindicate Coumadin® (warfarin) including: esophageal varices and clotting factor defects
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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他の：A
Combination therapy of GM-CSF, Thalidomide plus Docetaxel in patients with prostate cancer with a rising PSA
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fixed dose of 250 mcg/m2, 3 days per week by subcutaneous injection
他の名前：
Thalidomide by oral administration at a fixed dose of 200 mg.
Prophylactic Coumadin® by oral administration at a fixed dose of 2.5 mg to prevent thromboembolic events (DVT and TIA/stroke) during Thalidomide administration.
Thalidomide and Coumadin will be given daily at bedtime without interruption.
他の名前：
Docetaxel will be administered by intravenous piggyback over 1 hour at 75mg/m² every 3 weeks.
Pre-medication for the docetaxel infusion will consist of dexamethasone 8 mg administered orally 12 hours, 3 hours and 1 hour before docetaxel.
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 assess the relative efficacy of the combination of GM-CSF, Thalidomide and Docetaxel in patients with prostate cancer.
時間枠：during study (no data currently available)
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PI relocated, no data currently available
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during study (no data currently available)
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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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Collect data on hormonal responses produced by GM-CSF, Thalidomide and Docetaxel.
時間枠：during study (no data currently available)
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PI relocated, no data currently available
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during study (no data currently available)
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Evaluate safety and toxicity of the combination of GM-CSF, Thalidomide and Docetaxel for patients with hormone naïve prostate cancer.
時間枠：during study (no data currently available)
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PI relocated, no data currently available
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during study (no data currently available)
|
協力者と研究者
協力者
捜査官
- 主任研究者：Robert J Amato, DO、The Methodist Hospital Research Institute
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
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
- HMRI IRB#1006-0153
- PCa-06-102 (その他の識別子：Principal Investigator)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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