Ramucirumab Plus FOLFIRI Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastat… (NCT03081143) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Ramucirumab Plus FOLFIRI Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastatic Gastric Cancer, Who Failed One Prior Line of Palliative Chemotherapy
This clinical trial will evaluate whether it is beneficial in terms of prolongation of survival to combine FOLFIRI (standard treatment) with ramucirumab compared to the standard treatment of ramucirumab plus paclitaxel in patients with advanced gastric cancer after failure of one prior line of palliative chemotherapy. This trial aims to investigate the efficacy and safety of ramucirumab plus FOLFIRI (investigational arm A) compared to paclitaxel plus ramucirumab (control arm B).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent
✓. Male or female\* ≥ 18 years of age; Patients in reproductive age must be willing to use adequate contraception (that results in a failure rate of \<1% per year) during the study and for 3 months after the end of ramucirumab treatment (appropriate contraception is defined as surgical sterilization (e.g. bilateral tubal ligation, vasectomy), hormonal contraception (including oral contraceptive pills (combination of estrogen and progesterone), vaginal ring, injectables, implants, intrauterine devices (IUDs) and intrauterine hormone-releasing system (IUS)), nonhormonal IUDs and complete abstinence). Female patients with childbearing potential need to have a negative pregnancy test within 7 days before study start.
✓. Histologically proven gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction
✓. Metastatic or locally advanced disease, not amenable to potentially curative resection
✓. Phase II only: Documented objective radiological or clinical disease progression during or within 6 months of the last dose of first-line platinum and fluoropyrimidine doublet with or without anthracycline or docetaxel. Neoadjuvant/adjuvant treatment is not counted unless progression occurs \<6 months after completion of the treatment. In these cases neoadjuvant/adjuvant treatment is counted as one line.
✓. Measurable or non-measurable but evaluable disease
What they're measuring
1
OS Rate at 6 months primary endpoint for phase II
Timeframe: 6 months after randomization
2
overall survival (OS) co-primary endpoint for phase III
Timeframe: from date of randomization to 1 year after end of treatment
3
Objective Overall Response Rate (ORR) co-primary endpoint for phase III
Timeframe: from randomization for the time of treatment with a maximum of 1 year
Trial details
NCT IDNCT03081143
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
✕. Other tumor type than adenocarcinoma (e.g. leiomyosarcoma, lymphoma) or a second cancer except in patients with squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been effectively treated. Patients curatively treated and disease-free for at least 5 years will be discussed with the sponsor before inclusion
✕. Squamous gastric cancer
✕. Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
✕. Phase II only: Previous therapy with paclitaxel or FOLFIRI Phase III only: Previous therapy with FOLFIRI
✕. Current treatment with any anti-cancer therapy ≤ 2 weeks prior to study treatment start unless rapidly progressing disease is measured
✕. Concurrent treatment with any other anti-cancer therapy
✕. Previous exposure to a VEGF or VEGFR inhibitor or any antiangiogenic agent, or prior enrolment in this study
✕. Patient has undergone major surgery within 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy. The patient has elective or planned major surgery to be performed during the course of the clinical trial