Clinical trial · Interventional
Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen
A Phase II Study Of Cabazitaxel For Metastatic Gastroesophageal Adenocarcinomas That Have Relapsed After At Least One Line Of Chemotherapy
NCT01365130CI-TRIAL-00038112terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): As of 12/12/12 study closed to enrollment because study was determined to be ineffective.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effectiveness of Cabazitaxel, as well as safety and side effects for patients with advanced gastroesophageal cancer
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrooesophageal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| jevtana | Drug | Cabazitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- real drug
- description
- patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity
- interventionNames
- Drug: jevtana
Primary outcomes (1)
- measure
- Number of Patients Without Progression at 3 Months
- timeFrame
- every three cycles approx every 63 days
- description
- Response will be assessed via RECIST 1.1 criteria
Secondary outcomes (1)
- measure
- Number of Patients Experienced a Toxicity Associated With Cabazitaxel for Patients With Metastatic Gastroesophageal Adenocarcinomas That Have Progressed After at Least One Line of Therapy for Metastatic Disease.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients are required to have histologically or pathologically confirmed metastatic gastric or esophageal adenocarcinoma. * Patients must demonstrate relapse or progression after at least one prior line of chemotherapy for metastatic disease. * Patients must have measurable disease by CT scan or MRI * Absolute neutrophil count ≥ 1,500/uL, platelet ≥ 100,000/uL and Hgb \> 8.0 g/dl. * Total bilirubin ≤ upper institutional limit of normal (ULN), and AST or ALT ≤ 3x ULN; if liver metastases then AST or ALT \< 5x ULN * Peripheral neuropathy must be ≤ Grade 1 * Creatinine \< 2 x ULN * ECOG performance status 0 to 2 * Minimum life expectancy of 12 weeks. * Age older than 18 years. * Voluntary, signed written informed consent. * Women of childbearing potential must have a negative pregnancy test Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. Exclusion Criteria: * History of severe hypersensitivity reaction to Cabazitaxel or other drugs formulated with polysorbate 80. * Patients with known, untreated brain metastasis * Any uncontrolled severe, intercurrent illness. * Women who are breast-feeding. * Patients who have undergone major surgery, chemotherapy, or radiotherapy within the last 3 weeks. * Patients on concurrent anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.