Neoadjuvant Cetuximab, Fluorouracil, and Pelvic Irradiation in Treating Patients With Locally Advanced or Locally Recurrent Rectal Cancer
A Pilot Clinical Trial of Preoperative Cetuximab With Concurrent Continuous Infusion Fluorouracil and Pelvic Radiation in Patients With Local-Regionally Advanced Rectal Cancer
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the safety profile of neoadjuvant cetuximab, fluorouracil, and pelvic irradiation in patients with locally advanced or locally recurrent rectal cancer.
Secondary
- Determine the activity of this regimen, in terms of pathological complete response rate, in these patients.
OUTLINE: This is a non-randomized, open-label, pilot study.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64 and fluorouracil IV continuously on days 1-42. Patients undergo whole-pelvic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Treatment continues in the absence of disease progression or unacceptable toxicity.
Approximately 1-3 weeks after completion of study treatment, patients undergo surgical resection followed by adjuvant chemotherapy off-study.
Patients are followed for up to 5 years.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
New York
-
New York、New York、アメリカ、10021
- Memorial Sloan-Kettering 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 rectal adenocarcinoma meeting 1 of the following staging criteria:
Locally advanced disease
Resectable (uT3) disease
- Primary gross transmural tumor that is not adherent to adjacent pelvic structures by endorectal ultrasound
Primary tethered or unresectable (cT4 or uT4) disease
- Primary tumor is contiguous with or adherent or fixed to adjacent pelvic structures by clinical exam and CT scan
- Primary surgery would likely leave residual tumor
- Small volume extrapelvic metastases allowed
Recurrent disease after definitive resection
- Disease limited to the pelvis
- Requires combined modality treatment
- Epidermal growth factor receptor status-positive, -negative, or -unknown
- If previously treated with adjuvant fluorouracil-based chemotherapy, no disease recurrence during or within 12 months after completion of adjuvant therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0 -1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Hemoglobin > 8.0 g/dL
- Platelet count > 150,000/mm^3
Hepatic
- Not specified
Renal
- Creatinine ≤ 1.5 times upper limit of normal
Cardiovascular
- No myocardial infarction within the past 6 months
- No evidence of uncontrolled congestive heart failure requiring therapy
Other
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No known severe hypersensitivity to cetuximab or any of its excipients
- No uncontrolled infection
- No high-grade bowel obstruction (bowel lumen ≤ 1 cm) unless patient has undergone protective surgical diversion or endoscopic stenting procedure
- No other concurrent medical or psychiatric condition or disease that would preclude study participation
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior cetuximab
- No prior murine or chimeric monoclonal antibody therapy
- No prior biological response modifiers for metastatic colorectal cancer
- No concurrent anti-vascular endothelial growth factor/Flk-1 monoclonal antibody therapy
- No other concurrent antibody therapy or immunotherapy
- No concurrent gene therapy
- No concurrent vaccine therapy
- No concurrent angiogenesis inhibitors, including thalidomide
Chemotherapy
- See Disease Characteristics
- No prior chemotherapy for metastatic colorectal cancer
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy
Radiotherapy
- No prior radiotherapy for metastatic colorectal cancer
- No prior pelvic radiotherapy
- No other concurrent radiotherapy
Surgery
- See Disease Characteristics
- Fully recovered from prior oncologic or other major surgery
Other
- No other prior therapy that targets the epidermal growth factor receptor pathway
- No other concurrent experimental therapy or drugs
- No concurrent matrix metalloprotease inhibitors
- No concurrent participation in another clinical study
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:Cetuximab, Fluorouracil, and Pelvic Irradiation
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64 and fluorouracil IV continuously on days 1-42. Patients undergo whole-pelvic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Treatment continues in the absence of disease progression or unacceptable toxicity. Approximately 1-3 weeks after completion of study treatment, patients undergo surgical resection followed by adjuvant chemotherapy off-study. Patients are followed for up to 5 years. |
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 |
---|---|
Safety profile
時間枠:2 years
|
2 years
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Activity in terms of pathological complete response rate
時間枠:2 years
|
2 years
|
協力者と研究者
捜査官
- 主任研究者:Leonard B. Saltz, MD、Memorial Sloan Kettering Cancer Center
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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