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Clinical Trial VICCGI1211

Title

Phase IB/II Study of Induction Chemotherapy with XELOX, followed by Radiation Therapy, Carboplatin and RAD001 in Patients with Esophageal Cancer

Principal Investigator(s)

Bapsi Chak

Details

  • Protocol No. VICCGI1211
  • Open Date: 03/08/2013
  • Staging: Phase I/II
  • Age Group: Adults
  • Scope: National
  • Objective: Phase I - Determine the MTD and DLT of RAD001 in combination with fixed dose weekly carboplatin administered for up to 6 weekly treatments, and radiation therapy after induction therapy with XELOX Phase II - Determine the rate of pathologic complete remission after the same treatment.
  • Disease Sites: Esophageal
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics; Radiotherapy
  • Drugs: Carboplatin; Oxaliplatin; RAD001; Xeloda (Capecitabine)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01490749
  • Secondary Protocol No: CRAD001CUS159T

Description

None Provided.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Patients must have histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction.
patients can have disease that is resectable or unresectable.
• Patients must not have had prior chemotherapy or radiation therapy for esophageal cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Age ≥ 18.
• Adequate bone marrow, liver and renal function as assessed by the following:
• Absolute neutrophil count (ANC) ≥ 1500/mm³.
• Platelet count ≥ 100,000/mm³.
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement).
• Creatinine ≤ 1.5 x ULN.
• Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
• Women of childbearing potential must have a negative pregnancy test prior to first receiving investigational product. Sexually active women of childbearing potential (WOCBP) must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. All WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
• Patient must be willing to sign informed consent.
Exclusion Criteria:
• Patients currently receiving other investigational agents.
• Patients with known distant metastases.
• Patients who have received prior treatment with an mammalian target of rapamycin (mTOR) inhibitor (sirolimus, temsirolimus, everolimus).
• Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients.
• Known hypersensitivity to oxaliplatin, other platinum-containing compounds.
• Patients with known brain metastases.
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as a known history of HIV seropositivity.
• History of active hepatitis B or C.
• Co-administration with strong inhibitors of cytochrome P450 3A4 isoenzyme (CYP3A4) (e.g., ketoconazole, itraconazole, ritonavir) or P-glycoprotein (PgP).
• Patients with an active, bleeding diathesis.
• Patients with significant intercurrent medical illness (including New York Heart Association [NYHA] class III or IV heart disease, significant arrhythmias requiring medication, symptomatic coronary artery disease, myocardial infarction) within the previous 6 months.