Celecoxib, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery
Phase II Pilot Study of Pre-Operative Celecoxib (Celebrex) in Combination With Prolonged Venous Infusion 5FU and Radiation Therapy for Patients With Stage II/III Resectable Rectal Cancer
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, 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. Celecoxib may make tumor cells more sensitive to radiation therapy. Giving celecoxib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving celecoxib together with fluorouracil and radiation therapy works in treating patients with stage II or stage III rectal cancer that can be removed by surgery.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
- Determine cyclo-oxygenase-2 (COX-2) overexpression in patients with resectable stage II or III rectal cancer treated with neoadjuvant celecoxib, fluorouracil, and radiotherapy.
- Determine whether administration of celecoxib, a COX-2 inhibitor, results in changes in tumor (COX-2 overexpressing) levels of eicosanoids but not in the surrounding normal tissue.
- Determine if there is a greater change in protein and gene expression in post-treatment biopsies when compared to pretreatment biopsies that are greater for tumor (COX-2 overexpression) than in surrounding normal tissue.
- Determine whether patients who express the greatest degree of change in gene and protein expression are those most likely to respond to therapy.
- Assess the toxicities of concurrent treatment with celecoxib, fluorouracil, and radiotherapy.
OUTLINE: This is a pilot study.
Patients receive oral celecoxib twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy. Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive concurrent fluorouracil IV continuously for 5 weeks. Patients undergo radical resection 4-10 weeks after completion of chemoradiotherapy.
Patients undergo tumor biopsy at baseline and then at the time of surgical resection. Patients also undergo blood and urine collection at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. The specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 28 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
-
-
Tennessee
-
Nashville、Tennessee、アメリカ、37212
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
-
Nashville、Tennessee、アメリカ、37232-5671
- Vanderbilt-Ingram Cancer Center
-
-
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
DISEASE CHARACTERISTICS:
Histologically confirmed primary adenocarcinoma of the rectum
- Stage II or III disease
Distal border of tumor must be at or below the peritoneal reflection
- Distal border of the tumor must be within 12 cm of the anal verge by proctoscopic exam
- Tumor must be clinically resectable
- Transmural penetration beyond muscularis propria by transrectal ultrasound
- No high-grade obstruction
- No evidence of metastatic disease
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- WBC ≥ 4,000/mm³
- Platelet count ≥ 150,000/mm³
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other serious medical illness or psychiatric condition that would preclude study treatment
- No history of allergy to celecoxib or any other NSAIDs
- No history of allergy to sulfonamides
- No prior or concurrent malignancy except inactive noninvasive cervical carcinoma or skin cancer (excluding melanoma) or other cancer that has been disease free for ≥ 5 years
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the pelvis
- At least 7 days since prior and no other concurrent COX-2 inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs)
- No concurrent warfarin except low-dose warfarin (1 mg/day)
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：treatment intervention
|
twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy
Patients receive concurrent fluorouracil IV continuously for 5 weeks.
4-10 weeks after completion of chemoradiotherapy
Patients undergo radiotherapy 5 days a week for 5 weeks
at baseline and then at the time of surgical resection
blood and urine collected at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection.
specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.
|
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 |
時間枠 |
|---|---|
|
Pathologic complete response rate
時間枠：at time of surgery, day 5
|
at time of surgery, day 5
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Complete resection rate
時間枠：at time of surgery, day 5
|
at time of surgery, day 5
|
|
Patterns of failure
時間枠：during study, beginning day 5 forward
|
during study, beginning day 5 forward
|
|
Survival
時間枠：at time of death
|
at time of death
|
|
Toxicity
時間枠：5 days before surgery & 5 days after surgery
|
5 days before surgery & 5 days after surgery
|
協力者と研究者
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- VICC GI 0173
- P30CA068485 (米国 NIH グラント/契約)
- P50CA095103 (米国 NIH グラント/契約)
- VICC-GI-0173
- VICC-020031
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。
大腸がんの臨床試験
-
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