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Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

2019년 10월 4일 업데이트: Alliance for Clinical Trials in Oncology

A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma

PURPOSE: This phase II trial is studying how well gemcitabine and erlotinib work when given before and after surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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:

  1. 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
  2. To estimate the time to disease progression/relapse
  3. 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
  4. To evaluate the toxicity profile of preoperative gemcitabine plus erlotinib and the feasibility of postoperative gemcitabine plus erlotinib
  5. To evaluate response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib
  6. To identify molecular predictors of pancreatic cancer response to gemcitabine combined with erlotinib
  7. 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.

연구 유형

중재적

등록 (실제)

123

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • California
      • La Jolla, California, 미국, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • Los Angeles, California, 미국, 90027
        • Kaiser Permanente Medical Center - Los Angeles
      • Orange, California, 미국, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    • Connecticut
      • Bridgeport, Connecticut, 미국, 06606
        • St. Vincent's Medical Center
    • Florida
      • Lakeland, Florida, 미국, 33805
        • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
    • Indiana
      • Indianapolis, Indiana, 미국, 46237
        • St. Francis Hospital Cancer Care Services
    • Maryland
      • Baltimore, Maryland, 미국, 21229
        • St. Agnes Hospital Cancer Center
      • Baltimore, Maryland, 미국, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
    • Mississippi
      • Jackson, Mississippi, 미국, 39216
        • University of Mississippi Cancer Clinic
    • Nebraska
      • Omaha, Nebraska, 미국, 68114
        • Methodist Estabrook Cancer Center
    • New York
      • New York, New York, 미국, 10016
        • NYU Cancer Institute at New York University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    • Ohio
      • Dayton, Ohio, 미국, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, 미국, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, 미국, 45420
        • CCOP - Dayton
      • Kettering, Ohio, 미국, 45429
        • Charles F. Kettering Memorial Hospital
      • Troy, Ohio, 미국, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, 미국, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Oregon
      • Portland, Oregon, 미국, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
    • South Carolina
      • Spartanburg, South Carolina, 미국, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Virginia
      • Newport News, Virginia, 미국, 23606
        • Surgical Oncology Associates
    • West Virginia
      • Morgantown, West Virginia, 미국, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Madison, Wisconsin, 미국, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  • 캐나다
    • Ontario
      • Toronto, Ontario, 캐나다, M5G 2M9
        • Princess Margaret Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Eligibility Criteria:

  1. 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.

  2. 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.

  3. ≥ 18 years of age
  4. ECOG/Zubrod performance status of 0 or 1
  5. Baseline weight loss ≤ 15% of premorbid weight

  6. 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

  7. No history of the following:

    • Prior EGFR targeted therapy or therapy for pancreatic cancer
    • Active infection requiring intravenous antibiotics at the time of registration
  8. 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.
  9. No prior malignancy within 5 years of registration (Exceptions: non-melanoma skin cancer, in-situ cancers)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: 치료적 재래식 수술
의약품: erlotinib hydrochloride
oral administration
의약품: gemcitabine hydrochloride
Intravenous administration

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall Survival at 2 Years
기간: At 2 years post-registration
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.
At 2 years post-registration

2차 결과 측정

결과 측정
측정값 설명
기간
Resection Rate
기간: Up to 4 years postoperative chemotherapy treatment

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
Relapse/Progression-free Survival
기간: At 2 years post-registration
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.
At 2 years post-registration
Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI's Common Toxicity Criteria for Adverse Events
기간: Up to 4 years postoperative chemotherapy treatment
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.
Up to 4 years postoperative chemotherapy treatment
Response Rate
기간: Up to 4 years postoperative chemotherapy treatment
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.
Up to 4 years postoperative chemotherapy treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Alliance for Clinical Trials in Oncology

협력자

National Cancer Institute (NCI)
Astellas Pharma Inc
OSI Pharmaceuticals

수사관

  • 연구 의자: Peter W.T. Pisters, MD, M.D. Anderson Cancer Center

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2009년 4월 1일

기본 완료 (실제)

2015년 11월 1일

연구 완료 (실제)

2019년 6월 15일

연구 등록 날짜

최초 제출

2008년 8월 12일

QC 기준을 충족하는 최초 제출

2008년 8월 12일

처음 게시됨 (추정)

2008년 8월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 10월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 10월 4일

마지막으로 확인됨

2019년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ACOSOG-Z5041
  • U10CA076001 (미국 NIH 보조금/계약)
  • NCI-2009-00348 (기타 식별자: NCI Clinical Trial Reporting Office)
  • CDR0000609871 (레지스트리 식별자: NCI Physician Data Query)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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