Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the rate of prostate-specific antigen (PSA) decline and the number of patients reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising docetaxel and external-beam radiotherapy followed by docetaxel and prednisone in patients with hormone-naive prostate cancer who have a persistent or rising PSA after radical prostatectomy.
Secondary
- Determine the tolerability of this regimen in these patients.
- Determine the progression-free survival, based on PSA progression, of these patients.
- Determine the overall survival of patients treated with chemoradiotherapy for rising PSA after radical prostatectomy.
- Determine if the velocity of subsequent PSA failure impacts survival of these patients.
Tertiary
- Document subsequent therapy for patients whose previous treatment has failed and if there is a response to that therapy.
Quaternary: To collect data on a contemporary cohort to those on study that received radiation alone. We will match cancer and patient characteristics to determine if the variable of chemotherapy has any impact on outcomes.
OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and undergo external-beam radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
Beginning within 6 weeks after completion of chemoradiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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
-
-
Texas
-
San Antonio、Texas、アメリカ、78229-3900
- University of Texas Health Science Center at San Antonio
-
-
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 prostate cancer
- Prostate-specific antigen (PSA) level > 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago
- No lymph node-positive prostate cancer
No documented metastatic disease
- CT scan of the abdomen and pelvis negative (within the past 6 months)
- No bone pain OR negative bone scan (within the past 6 months)
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Bilirubin normal
- ALT and AST ≤ 1.5 times upper limit of normal
- Alkaline phosphatase normal
- Fertile patients must use effective contraception
- No peripheral neuropathy > grade 1
- No other malignancy within the last 5 years that could affect the diagnosis or assessment of prostate cancer
- No serious illness with a life expectancy of < 5 years
- No concurrent medical, psychological, or social circumstance that would preclude study compliance
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Exclusion Criteria:
- No prior orchiectomy
- No prior chemotherapy regimen for this disease
- No prior pelvic radiotherapy
No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride
- Preoperative androgen manipulation for a duration of ≤ 3 months allowed
- No prior immunotherapy
- No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other systemic radioisotopes
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
No concurrent herbal or alternative regimens including, but not limited to, any of the following:
- Saw palmetto
- PC-SPES
- Shark cartilage
- No other concurrent investigational agents
- No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for replacement steroids)
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：Docetaxel (Single Arm)
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles).
Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel
|
Docetaxel 20mg/m2/week IV every week during standard of care radiation treatment (7 cycles).
Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
他の名前：
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles).
Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
他の名前：
Radical prostatectomy as part of standard care
Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue.
The initial dose will be 4500 cGy.
With the final boost, the total dose will be 6840-6900 cGy.
(4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
|
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 |
|---|---|---|
|
Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
時間枠：5 years
|
Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..
|
5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
全生存
時間枠：5年
|
5年
|
|
|
Progression-free Survival Based on PSA Progression
時間枠：5 years
|
Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up.
|
5 years
|
|
Correlation Between Velocity of Subsequent PSA Failure and Survival
時間枠：5 years
|
5 years
|
協力者と研究者
捜査官
- スタディチェア：Gregory P. Swanson, MD、The University of Texas Health Science Center at San Antonio
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 (実際)
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
- CDR0000486733
- HSC20050377H. (その他の識別子：UTHSCSA IRB)
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。
前立腺がんの臨床試験
-
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