- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00040859
Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the objective tumor response rate of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with oxaliplatin and capecitabine.
Secondary
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR.
Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy).
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Iowa
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Sioux City, Iowa, 미국, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, 미국, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, 미국, 51104
- Mercy Medical Center - Sioux City
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South Dakota
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Sioux Falls, South Dakota, 미국, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, 미국, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, 미국, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists
- Unresectable disease
- Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach
- Measurable disease
- No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- AST no greater than 3 times ULN
- Alkaline phosphatase no greater than 2 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- Able to swallow capecitabine
- No unresolved gastrointestinal bleeding
- No uncontrolled infection
- No chronic debilitating disease
- No peripheral neuropathy grade 2 or greater
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy or biological therapy for recurrent or metastatic disease
- No concurrent biologic agents
Chemotherapy:
- No prior chemotherapy for recurrent or metastatic disease
- Prior adjuvant or neoadjuvant chemotherapy (including combination chemotherapy and radiotherapy) allowed
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Chemotherapy
- No prior radiotherapy for recurrent or metastatic disease
- No prior radiotherapy to more than 25% of the bone marrow
- Prior adjuvant or neoadjuvant radiotherapy allowed
- More than 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- More than 4 weeks since prior abdominal exploration with surgical resection
- More than 3 weeks since prior abdominal exploration without surgical resection
Other:
- No concurrent oral cryotherapy during oxaliplatin administration
공부 계획
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: oxaliplatin + capecitabine
Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR. Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy). Patients are followed every 3 months for 1 year and then every 6 months for 2 years. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Objective tumor response rate
기간: Up to 3 years
|
Up to 3 years
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
전반적인 생존
기간: 최대 3년
|
최대 3년
|
|
진행 시간
기간: 최대 3년
|
최대 3년
|
|
삶의 질
기간: 최대 3년
|
최대 3년
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Jatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. doi: 10.3892/ijo_00000535.
- Jatoi A, Murphy BR, Foster NR, Nikcevich DA, Alberts SR, Knost JA, Fitch TR, Rowland KM Jr; North Central Cancer Treatment Group. Oxaliplatin and capecitabine in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia: a phase II study from the North Central Cancer Treatment Group. Ann Oncol. 2006 Jan;17(1):29-34. doi: 10.1093/annonc/mdj063. Epub 2005 Nov 22.
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
- NCCTG-N0149
- NCI-2012-02471 (레지스트리 식별자: CTRP (Clinical Trials Reporting System))
- CDR0000069413 (레지스트리 식별자: PDQ (Physician Data Query))
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