Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

Vetëm përdoruesit e regjistruar mund të përkthejnë artikuj

Identifikohuni Regjistrohu

Lidhja ruhet në kujtesën e fragmenteve

StatusiPërfunduar

Sponsorët

US Oncology Research

Bashkëpunëtorë

Eli Lilly and Company

Sanofi

TRAJTIM KLINIKAL: NCT00517829

BioSeek: nct00517829

Fjalë kyçe

Abstrakt

The purpose of this research study is to find out what effects (good and bad) docetaxel, oxaliplatin, and cetuximab have on gastric or GEJ cancer.

Përshkrim

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.

Datat

Verifikuar së fundmi:	09/30/2016
Paraqitur së pari:	08/14/2007
Regjistrimi i vlerësuar u dorëzua:	08/15/2007
Postuar së pari:	08/16/2007
Përditësimi i fundit i paraqitur:	10/13/2016
Përditësimi i fundit i postuar:	11/27/2016
Data e paraqitjes së rezultateve të para:	01/11/2016
Data e paraqitjes së parë të rezultateve të QC:	01/11/2016
Data e rezultateve të para të postuara:	02/10/2016
Data e fillimit të studimit aktual:	06/30/2007
Data e vlerësuar e përfundimit primar:	03/31/2012
Data e vlerësimit të përfundimit të studimit:	03/31/2012

Gjendja ose sëmundja

Gastric Cancer Adenocarcinoma Metastatic

Ndërhyrja / trajtimi

Drug: Docetaxel

Drug: 2- Docetaxel plus oxaliplatin plus cetuximab

Drug: oxaliplatin

Faza

Faza 2

Grupet e krahëve

Krah	Ndërhyrja / trajtimi
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.

Kriteret e pranimit

Moshat e pranueshme për studim	18 Years Për të 18 Years
Gjinitë e pranueshme për studim	All
Pranon Vullnetarë të Shëndetshëm	po
Kriteret	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

Rezultati

Masat Kryesore të Rezultateve

1. Progression-free Survival [Treatment will continue until disease progression or intolerable toxicity, up to 2 years]

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. 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.

Masat dytësore të rezultateve

1. Overall Survival [Treatment will continue until disease progression or intolerable toxicity]

OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

2. Objective Response Rate (ORR) [Treatment will continue until disease progression or intolerable toxicity.]

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

3. Time to Response [Treatment will continue until disease progression or intolerable toxicity]

For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.

4. Duration of Response [Treatment will continue until disease progression or intolerable toxicity]

The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.