- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00217581
Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer
Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with oxaliplatin and docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the time to progression in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma treated with bevacizumab, oxaliplatin, and docetaxel.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine time to treatment failure and overall survival of patients treated with this regimen.
- Determine the changes in general and disease-specific quality of life, in terms of response to treatment, in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 120 minutes, and docetaxel IV over 60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 18-23 months.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109-0942
- University of Michigan Comprehensive Cancer Center
-
Detroit, Michigan, 미국, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
Detroit, Michigan, 미국, 48201
- Veterans Affairs Medical Center - Detroit
-
-
Ohio
-
Columbus, Ohio, 미국, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed gastric or gastroesophageal junction adenocarcinoma
- Locally advanced unresectable or metastatic disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10mm by spiral CT scan
- Bone metastases, ascites, or pleural effusions are not considered measurable disease
- Evaluable disease must be present outside previously irradiated field
- No CNS or brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- SWOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 mg/dL
- No evidence of bleeding diathesis or coagulopathy
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ ULN
- INR < 1.5
Renal
- Creatinine < 2.0 mg/dL
- Urine protein:creatinine ratio < 1.0
Cardiovascular
- No history of deep venous thrombosis requiring anticoagulation
- No active angina
- No myocardial infarction within the past year
- No cerebrovascular accident within the past year
- No uncontrolled hypertension (systolic blood pressure [BP] > 170 mm Hg and/or diastolic BP > 100 mm Hg) despite medical management
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No peripheral neuropathy > grade 1
- No history of allergy to any of the study drugs or drugs formulated with polysorbate 80
- No known HIV infection
- No active peptic ulcer disease
- No serious non-healing wound, ulcer, or bone fracture
- No unresolved bacterial infection requiring antibiotics
- No other active malignancy within the past 3 years except for cancers that have been treated with a curative intent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No prior chemotherapy for gastric cancer unless disease relapsed > 6 months after completion of non-taxane adjuvant chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since radiotherapy
Surgery
- At least 4 weeks since prior surgery or open biopsy (except indwelling venous catheter placement)
- No concurrent surgery
Other
- At least 4 weeks since prior and no concurrent participation in another experimental drug trial
- No concurrent full-dose anticoagulation
- No concurrent experimental drugs
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: Docetaxel, Oxaliplatin & Bevacizumab
Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes.
If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
|
Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes.
If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
다른 이름들:
Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70
mg/m(2), IV over 60 minutes, day 1 of each cycle;
다른 이름들:
Must be administered 3rd after Bevacizumab and Docetaxel.
75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Time to Progression
기간: After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
|
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
|
After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Response Rate by RECIST Criteria
기간: After every 2 cycles (1 cycle =21 days)
|
Percentage of Participants with response by RECIST criteria until progression
|
After every 2 cycles (1 cycle =21 days)
|
Toxicity Profile
기간: At 21 days following completion of study treatment
|
Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading.
|
At 21 days following completion of study treatment
|
Time to Treatment Failure
기간: Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
|
Time to treatment failure using the Kaplan-Meier method
|
Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
|
Overall Survival
기간: Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years
|
Overall survival using the Kaplan-Meier method
|
Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Philip A. Philip, MD, PhD, FRCP, Barbara Ann Karmanos Cancer Institute
- 수석 연구원: Basil El-Rayes, MD, Barbara Ann Karmanos Cancer Institute
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000441641
- P30CA022453 (미국 NIH 보조금/계약)
- WSU-D-2840
- UMCC-2005-052
- AVENTIS-WSU-D-2840
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. .
위암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)모병피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
Jonsson Comprehensive Cancer Center아직 모집하지 않음전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Rashmi Verma, MDNational Cancer Institute (NCI)모병거세저항성 전립선암 | 전이성 전립선 선암종 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.종료됨2기 전립선암 AJCC v8 | IIIA기 전립선암 AJCC v8 | IIIB기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | 3기 전립선암 AJCC v8 | IIIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
-
Jonsson Comprehensive Cancer Center종료됨생화학적으로 재발하는 전립선암 | 전이성 전립선암 | 뼈의 전이성 악성 신생물 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
Bevacizumab에 대한 임상 시험
-
University of Utah빼는
-
National Center for Tumor Diseases, HeidelbergPfizer; Roche Pharma AG종료됨
-
National Taiwan University Hospital종료됨