Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma
調査の概要
詳細な説明
This is a single arm, non-randomized phase II study. Eligible, fully registered patients will receive preoperative chemotherapy consisting of gemcitabine plus erlotinib. Preoperative chemotherapy will be followed by exploratory laparotomy and pancreaticoduodenectomy. Patients will then receive postoperative chemotherapy consisting of gemcitabine plus erlotinib. Up to 123 patients will be accrued to this study, with the expectation that 78 patients will remain fully eligible and evaluable for the primary endpoint. The primary and secondary objectives for the study are listed below.
Primary Objective:
To estimate the proportion of patients alive at two years from the date of registration
Secondary Objectives:
- To determine the resection rate (defined as the fraction of patients who proceed to planned surgery with removal of primary tumor [R0/R1]) following induction treatment with gemcitabine plus erlotinib
- To estimate the time to disease progression/relapse
- To evaluate the rate of R0, R1, and R2 resections (defined as per the 6th edition of the AJCC Cancer Staging Manual) in patients treated with preoperative gemcitabine plus erlotinib chemotherapy
- To evaluate the toxicity profile of preoperative gemcitabine plus erlotinib and the feasibility of postoperative gemcitabine plus erlotinib
- To evaluate response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib
- To identify molecular predictors of pancreatic cancer response to gemcitabine combined with erlotinib
- To identify genetic profiles of pancreatic adenocarcinoma that may be associated with response to neoadjuvant therapy
After completion of postoperative chemotherapy treatment, patients are followed every 3 months for 2 years and then every 6 months for 2 years.
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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California
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La Jolla、California、アメリカ、92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Los Angeles、California、アメリカ、90027
- Kaiser Permanente Medical Center - Los Angeles
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Orange、California、アメリカ、92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
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Connecticut
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Bridgeport、Connecticut、アメリカ、06606
- St. Vincent's Medical Center
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Florida
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Lakeland、Florida、アメリカ、33805
- Lakeland Regional Cancer Center at Lakeland Regional Medical Center
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Indiana
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Indianapolis、Indiana、アメリカ、46237
- St. Francis Hospital Cancer Care Services
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Maryland
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Baltimore、Maryland、アメリカ、21229
- St. Agnes Hospital Cancer Center
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Baltimore、Maryland、アメリカ、21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Mississippi
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Jackson、Mississippi、アメリカ、39216
- University of Mississippi Cancer Clinic
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Nebraska
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Omaha、Nebraska、アメリカ、68114
- Methodist Estabrook Cancer Center
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New York
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New York、New York、アメリカ、10016
- NYU Cancer Institute at New York University Medical Center
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Ohio
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Dayton、Ohio、アメリカ、45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton、Ohio、アメリカ、45415
- Samaritan North Cancer Care Center
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Dayton、Ohio、アメリカ、45420
- CCOP - Dayton
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Kettering、Ohio、アメリカ、45429
- Charles F. Kettering Memorial Hospital
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Troy、Ohio、アメリカ、45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Oklahoma
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Tulsa、Oklahoma、アメリカ、74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Oregon
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Portland、Oregon、アメリカ、97213-2967
- Providence Cancer Center at Providence Portland Medical Center
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South Carolina
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Spartanburg、South Carolina、アメリカ、29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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Virginia
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Newport News、Virginia、アメリカ、23606
- Surgical Oncology Associates
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West Virginia
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Morgantown、West Virginia、アメリカ、26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Madison、Wisconsin、アメリカ、53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Ontario
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Toronto、Ontario、カナダ、M5G 2M9
- Princess Margaret Hospital
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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
Eligibility Criteria:
Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process.
NOTE: Patients with tumors of the pancreatic neck, body or tail are not eligible. Patients with evidence of neuroendocrine tumors, duodenal adenocarcinoma, or ampullary adenocarcinoma are not eligible.
Localized, potentially resectable tumors as defined below. All patients must be staged with a chest X-ray or CT, and abdominal CT (contrast-enhanced, helical thin-cut) or MRI. Radiological resectability is defined by the following criteria on abdominal imaging:
- No evidence of tumor extension to the celiac axis, hepatic artery, or superior mesenteric artery
- No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence
- No evidence of visceral or peritoneal metastases
NOTE: Patients with borderline resectable or marginally resectable pancreatic cancer are not eligible. Patients must meet all objective imaging criteria outlined above.
- ≥ 18 years of age
- ECOG/Zubrod performance status of 0 or 1
- Baseline weight loss ≤ 15% of premorbid weight
Patient must have adequate hematologic, renal, and hepatic function as defined by:
- WBC ≥ 2,000 cells/mm³
- ANC ≥ 1,500 cells/mm³
- Platelets ≥ 100,000 cells/mm³
- Serum bilirubin ≤ 2.5 mg/dL
- Serum creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance of ≥ 50 ml/min (24 hour urine collection)
- ALT < 2.5 times upper limit of normal (ULN)
- AST < 2.5 times ULN
- Albumin ≥ 3.2 g/dl
No history of the following:
- Prior EGFR targeted therapy or therapy for pancreatic cancer
- Active infection requiring intravenous antibiotics at the time of registration
- Non-pregnant and non-breast feeding. Female participants of child bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic ≥ 12 months to be considered not of childbearing potential. All patients of reproductive potential must agree to use an effective method of birth control while receiving study therapy.
- No prior malignancy within 5 years of registration (Exceptions: non-melanoma skin cancer, in-situ cancers)
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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実験的：Neoadjuvant therapy + Surgery + Adjuvant therapy
As part of neoadjuvant therapy, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Within 3-6 weeks after completion of neoadjuvant therapy, patients undergo pancreaticoduodenectomy and patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post surgery.
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oral administration
Intravenous administration
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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 |
|---|---|---|
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Overall Survival at 2 Years
時間枠：At 2 years post-registration
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The primary endpoint of this trial is 2-year overall survival, which will be evaluated as the proportion of treatment successes.
A treatment success is defined to be an evaluable patient who is alive at two years from the date of registration.
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At 2 years post-registration
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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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Resection Rate
時間枠：Up to 4 years postoperative chemotherapy treatment
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The resection rate is defined as the fraction of patients that proceed to planned surgery with removal of primary tumor (R0/R1) following neoadjuvant treatment with gemcitabine plus erlotinib.The resection rate will be estimated by the binomial point estimate, i.e. as the number of patients that undergo the planned surgery with removal of the primary tumor following neoadjuvant treatment with gemcitabine plus erlotinib divided by the number of evaluable patients. This quantity will also be estimated with a 95% binomial confidence interval. Curative resection (R0) is defined as macroscopically and microscopically complete resection (with microscopic surgical margin assessment according to AJCC Staging Principles). An R1 resection is defined as macroscopically complete tumor removal with any positive microscopic surgical margin (bile duct, pancreatic parenchyma, or SMA margins). |
Up to 4 years postoperative chemotherapy treatment
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Relapse/Progression-free Survival
時間枠：At 2 years post-registration
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Relapse/progression-free survival is defined as the time from date of registration to the date of documentation of disease recurrence/progression.
If a patient dies without documentation of disease recurrence/progression, the patient will be considered to have had disease recurrence/progression at the time of their death unless there is sufficient documented evidence to conclude no recurrence/progression occurred prior to death.
If a patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation occurred.
If a patient is lost to follow-up, s/he will be censored at the data of last contact.
The distribution of disease-free survival will be estimated using the method of Kaplan and Meier.
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At 2 years post-registration
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Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI's Common Toxicity Criteria for Adverse Events
時間枠：Up to 4 years postoperative chemotherapy treatment
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The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
These patterns will be summarized with descriptive statistics.
The number of patients reporting grade 3 or higher adverse events as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here.
A complete list of all reported adverse events is reported in the Adverse Events section of this report.
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Up to 4 years postoperative chemotherapy treatment
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Response Rate
時間枠：Up to 4 years postoperative chemotherapy treatment
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The response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib and rates of accurate pathologic assessment of the resected tumor specimen according to College of American Pathology guidelines will be estimated with a binomial point estimate and corresponding 95% confidence intervals.
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Up to 4 years postoperative chemotherapy treatment
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協力者と研究者
捜査官
- スタディチェア：Peter W.T. Pisters, MD、M.D. Anderson Cancer Center
研究記録日
主要日程の研究
研究開始 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ACOSOG-Z5041
- U10CA076001 (米国 NIH グラント/契約)
- NCI-2009-00348 (その他の識別子：NCI Clinical Trial Reporting Office)
- CDR0000609871 (レジストリ識別子：NCI Physician Data Query)
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