Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen

Stopped early · Phase 2

Conditions studied: Esophageal, Gastrooesophageal Cancer, Gastric Cancer

In brief

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

Key facts

Study ID

NCT01365130

Run by

howard safran

People needed

15

Starts

2011-06-01

Expected to finish

2013-08-01

Last updated by the study team

2019-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Memorial Hospital — Pawtucket, Rhode Island, United States
• Brown University Oncology Research Group — Providence, Rhode Island, United States
• Roger Williams — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.