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

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: howard safran
• Collaborators: Rhode Island Hospital; Roger Williams Medical Center; The Miriam Hospital

Criteria

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