Docetaxel+Oxali+/-Cetux Met Gastric/GEJ
Түлхүүр үгс
Хураангуй
Тодорхойлолт
This is a Phase II, open- label, randomized, noncomparative study. Patients will be stratified at randomization by ECOG PS. There is no intent to have equal numbers of patients for each PS (ie, 0, 1, and 2), but rather stratification will be conducted to ensure that the 2 treatment arms are well-balanced for ECOG PS.
Patients will be randomly assigned to either Arm 1 - Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour, followed by Eloxatin 130 mg/m2 IV over 2 hours or Arm 2 - Taxotere 60 mg/m2 as an IV infusion over 1 ho ur, followed by Eloxatin 130mg/m2 IV over 2 hours, followed by ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes. Taxotere and Eloxatin will be given on Day 1 of each 21-day cycle; ERBITUX is given on Days 1, 8, and 15 of each cycle.
Treatment will continue until disease progression or intolerable toxicity. Patients who achieve a CR will receive an additional 2 cycles of treatment. Patients will be limited to 24 months of participation, counted from the date of the first dose of study drug.
Огноо
Сүүлд баталгаажуулсан: | 09/30/2016 |
Эхлээд оруулсан: | 08/14/2007 |
Тооцоолсон элсэлтийг оруулсан: | 08/15/2007 |
Эхлээд нийтэлсэн: | 08/16/2007 |
Сүүлийн шинэчлэлтийг оруулсан: | 10/13/2016 |
Сүүлийн шинэчлэлтийг нийтэлсэн: | 11/27/2016 |
Эхний ирүүлсэн үр дүнгийн огноо: | 01/11/2016 |
Анхны ирүүлсэн QC-ийн үр дүнгийн огноо: | 01/11/2016 |
Эхний байрлуулсан үр дүнгийн огноо: | 02/10/2016 |
Сургалтын бодит эхлэх огноо: | 06/30/2007 |
Тооцоолсон анхан шатны ажил дуусах огноо: | 03/31/2012 |
Судалгааны ажлыг дуусгах өдөр: | 03/31/2012 |
Нөхцөл байдал эсвэл өвчин
Хөндлөнгийн оролцоо / эмчилгээ
Drug: Docetaxel
Drug: 2- Docetaxel plus oxaliplatin plus cetuximab
Drug: oxaliplatin
Үе шат
Arm Groups
Гар | Хөндлөнгийн оролцоо / эмчилгээ |
---|---|
Active Comparator: 1- Docetaxel plus Oxaliplatin Docetaxel as an intravenous (IV) infusion over 1 hour, followed by oxaliplatin IV over 2 hours | |
Active Comparator: 2- Docetaxel plus oxaliplatin plus cetuximab Docetaxel 60 mg/m2 as an IV infusion over 1 ho ur, followed by oxaliplatin 130 mg/m2 IV over 2 hours, followed by cetuximab 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes. | Drug: 2- Docetaxel plus oxaliplatin plus cetuximab ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes. |
Эрхийн шалгуур
Суралцах боломжтой нас | 18 Years Хэнд 18 Years |
Суралцах боломжтой хүйс | All |
Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг | Тийм ээ |
Шалгуур үзүүлэлтүүд | Inclusion Criteria: - Patient has histologically confirmed Stage IV adenocarcinoma of the GEJ/stomach Note: Adjuvant radiation plus treatment with 5-FU and leucovorin is permitted, but not required. - Patients must have measurable disease - Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 - Patient is greater than 18 years of age - If present, any pre-existing (current) peripheral neuropathy must be ≤ Grade 1 - Patient's laboratory values must fall within the limits set forth in section 4.2 of the protocol - Patient has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential) - If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a 2 month period thereafter - Patient (or guardian) has signed a Patient Informed Consent Form - Patient (or guardian) has signed a Patient Authorization Form Exclusion Criteria: - Patient has any metastatic disease other than that defined in section 4.2 (criterion #1) - Patient has had prior treatment that included anything other than adjuvant radiation plus treatment with 5-FU and leucovorin. Prior treatment must have been completed > 6 months prior to registration in current study. No other prior regimens are allowed. Note: Adjuvant radiation plus treatment with 5-FU and leucovorin is permitted, but not required. - If present, any peripheral neuropathy is > Grade 1 - Patient has a known hypersensitivity to Taxotere (or any drug formulated with Polysorbate-80), or Eloxatin - Has had a prior severe infusion reaction (Grade 4) to a monoclonal antibody - Has received prior therapy, at any time, which specifically and directly targets the EGFR pathway - Patient is receiving concurrent immunotherapy or any other concurrent treatment for their cancer - Has had prior stem cell or bone marrow transplant or any organ transplant with the exception of corneal transplant or cadaver bone graft - Has a significant history of uncontrolled cardiac disease; ie, uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection fraction (LVEF<50%) - Has evidence of CNS involvement (CNS imaging is not required for study enrollment unless clinically suspected CNS disease is present.) - Patient has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection - Patient is known to be HIV positive or have a history of hepatitis B or C - Patient has a history of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix , or superficial transitional cell carcinoma of the bladder), which could affect the diagnosis or assessment of current condition. - Patient is a pregnant or lactating woman |
Үр дүн
Анхан шатны үр дүнгийн арга хэмжээ
1. Progression-free Survival [Treatment will continue until disease progression or intolerable toxicity, up to 2 years]
Хоёрдогч үр дүнгийн арга хэмжээ
1. Overall Survival [Treatment will continue until disease progression or intolerable toxicity]
2. Objective Response Rate (ORR) [Treatment will continue until disease progression or intolerable toxicity.]
3. Time to Response [Treatment will continue until disease progression or intolerable toxicity]
4. Duration of Response [Treatment will continue until disease progression or intolerable toxicity]