Study of PEP02, Irinotecan or Docetaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
A Randomized Phase II Study of PEP02, Irinotecan or Docetaxel as a Second Line Therapy in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
연구 개요
상세 설명
Palliative chemotherapy has been shown to improve survival compared with best supportive care alone in patients with unresectable or recurrent gastric cancer. There is no standard second-line chemotherapy for advanced gastric cancer and no randomized-controlled trial data suggest a benefit of second-line chemotherapy compared with supportive care alone. Response rates of second-line therapy in phase II trials are similar to those seen for other cancers that are more commonly retreated. Combination therapy may achieve higher response rates than single agents, however, the survival outcome are the same. In addition, data suggest that patients may obtain symptomatic benefits from second-line therapy. In comparison to the toxicity profile of single agent with combination regimen, patients are more tolerable to single agent therapy than combination.
Based on the previous clinical experience in second line chemotherapy of advanced gastric cancer, the single agent of PEP02, irinotecan and docetaxel are selected as the regimens for this randomized phase II study. The efficacy and toxicity outcome of the three-arm design will be a valuable reference for future combination therapy or phase III study design.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Chiayi, 대만
- Chang Gung Memorial Hospital - Chiayi
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LinKou, 대만
- Chang Gung Memorial Hospital - Linkou
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Tainan, 대만, 704
- National Cheng Kung University Hospital
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Taipei, 대만, 112
- Taipei Veterans General Hospital
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Taipei, 대만, 25115
- Mackay Memorial Hospital
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Seoul, 대한민국, 135-710
- Samsung Medical Center
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Seoul, 대한민국, 138-736
- Asan Medical Center
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Seoul, 대한민국, 410-769
- National Cancer Center
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Mostar, 보스니아 헤르체고비나, 36 000
- Clinical hospital Mostar
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Sarajevo, 보스니아 헤르체고비나, 71 000
- Clinical Centre University of Sarajevo
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Barcelona, 스페인, 08035
- Hospital Universitario Vall d'Hebron
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Elche, 스페인, 03203
- Hospital General Universitario de Elche
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Madrid, 스페인, 28040
- Hospital Clinico San Carlos
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Santander, 스페인, 39008
- Hospital Universitario Marqués de Valdecilla
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Cambridge, 영국, CB2 2QQ
- Addenbrookes Hospital Oncology Center
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London, 영국, SE19RT
- Guy's & St Thomas' NHS Foundation Trust
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Maidstone, 영국, ME16 9QQ
- Kent Oncology Centre, Maidstone Hospital
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Southampton, 영국, SO16 6YD
- Southampton University Hospital
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Surrey, 영국, SM2 5PT
- The Royal Marsden Hospital
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Rijeka, 크로아티아, 51 000
- University hospital centre Rijeka
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Zagreb, 크로아티아, 10 000
- University Hospital Centre Zagreb
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Zagreb, 크로아티아, 10 000
- University Hospital Centre Dubrava
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of gastric or gastroesophageal junction
- Failed to only one systemic chemotherapy for locally advanced or metastatic disease, including patients whose diseases recur within 6 months after (neo)adjuvant chemotherapy. Chemotherapy administered with concurrent radiotherapy is NOT considered as systemic chemotherapy.
- Have at least one measurable lesion according to the RECIST criteria
- Aged above or equal to 18 years, at the time of acquisition of informed consent
- With ECOG performance status 0, 1, or 2
- Life expectancy equal to or more than 3 months
- With adequate organ and marrow function as defined below:
- With ability to understand and the willingness to sign a written Informed Consent Form
Exclusion Criteria:
- Had systemic chemotherapy within 3 weeks before the commencement of study treatment
- Had radiotherapy within 4 weeks before the commencement of study treatment
- With known brain metastasis
- With active multiple cancers or had treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
- With prior irinotecan or taxane (paclitaxel, docetaxel) treatment
- Have received irradiation affecting > 30% of the active bone marrow
- Had major surgery within 4 weeks of the start of study treatment (laparotomy, line placement is not considered major surgery)
- Have not recovered from prior treatments
- With preexisting peripheral neuropathy > grade 2
- With history of allergic reaction to liposome product or other drugs formulated with polysorbate
- With uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, active gastrointestinal bleeding, watery stools, central nervous system disorders or psychiatric illness/social situation that would limit compliance with study requirements or judged to be ineligible for the study by the investigator
- Have received any investigational agents within 3 weeks preceding the start of study treatment
- Pregnant or breastfeeding females (a pregnancy test must be performed on all female patients who are of child-bearing potential before entering the study, and the result must be negative)
- With intestinal obstruction
- Have received St. John's Wort, CYP3A4 inducing anticonvulsants (phenytoin, phenobarbital, and carbamazepine), rifampin and rifabutin within two weeks, or ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem and verapamil within one week before the administration of study medications
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1. PEP02
liposome irinotecan
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120 mg/m2, IV infusion for 90 minutes on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
다른 이름들:
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활성 비교기: 2. irinotecan
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300 mg/m2, IV infusion on day 1 of each 21 day as a treatment cycle.
Number of Cycles: until progression or unacceptable toxicity develops.
다른 이름들:
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활성 비교기: 3. docetaxel
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75 mg/m2, IV infusion for 60 minutes on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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객관적인 종양 반응
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2차 결과 측정
결과 측정 |
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progression-free survival, duration of tumor response, time to progression, time to treatment failure, disease control rate, 1-year survival rate,and overall survival; pharmacokinetics and pharmacogenetics of PEP02 and irinotecan
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: David Cunningham, The Royal Marsden Hospital, London & Surrey, UK
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PEP0206
- EudraCT number: 2006-006452-35
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