Clinical trial · Interventional
Study of Nab-Paclitaxel and Ramucirumab as Second-line Treatment for Patients With Metastatic Gastroesophageal Cancer
Phase II Study of Nab-Paclitaxel and Ramucirumab for the Second-line Treatment of Patients With Metastatic Gastroesophageal Cancer
NCT02317991CI-TRIAL-00059446completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether nab-Paclitaxel (Abraxane®) and ramucirumab (Cyramza®) are effective when used in combination for treating patients with metastatic gastroesophageal cancer who have either progressed or not responded to prior therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroesophageal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| ramucirumab | Biological | Ramucirumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nab-paclitaxel and ramucirumab
- description
- All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest). Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
- interventionNames
- Drug: nab-paclitaxel
- Biological: ramucirumab
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- up to 1 year
- description
- Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation in Solid Tumors Criteria (RECIST v1.1), or death on study from any cause. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Participants who are alive and free from disease progression were censored at the date of the last adequate tumor assessment. If no adequate post-treatment tumor assessments were obtained for participants, PFS will be censored on Day 1.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically confirmed metastatic adenocarcinoma of the esophagus, GE junction, or stomach who progressed on one prior line of chemotherapy in the metastatic setting. 2. Measurable disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 4. Adequate hematologic, renal, and hepatic functions 5. Patients must have \< Grade 2 pre-existing peripheral neuropathy (per National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v 4.03) 6. Life expectancy \> 3 months Exclusion Criteria: 1. Patients who have received any other investigational agents, chemotherapy, biologic therapy, or radiation therapy within the 28 days prior to Day 1 of the study. For investigational, chemotherapy, or biologic therapy, patients will be allowed on study if five half-lives or greater have elapsed since last dose of drug or 28 days, whichever is shorter. 2. Patients with prior taxane chemotherapy or agents which act by primary anti-angiogenic mechanisms. 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit safety or compliance with study requirements or may interfere with the interpretation of the results. 4. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study initiation, or anticipation of need for major surgical procedure during the course of the study. 5. Evidence or history of uncontrolled hypertension, proteinuria, non-healing wound, ulcer, bone fracture, hemoptysis, valvular disease, abdominal fistula, GI perforation, intra-abdominal abscess, bleeding diathesis or coagulopathy that would exclude patients from treatment with anti-angiogenesis agents. 6. Therapeutic anticoagulation with coumarin-derivatives will not be permitted. However, a maximum daily dose of 1 mg will be permitted for port line patency. Anticoagulation with low molecular weight heparin or anti-Factor Xa agents will be allowed. 7. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise safety of treatment as so judged by treating physician (i.e., severely impaired lung function, severe infection, ventricular arrhythmias active ischemic heart disease, known active vasculitis of any cause, chronic liver or renal disease).
References
Publications (0)
Data not yet available
No reference posted for this study.